| Also tagged in: Access to health care, Administrative procedure, Affordable housing, Afghanistan, Aged, Agricultural subsidies, Agriculture, Aid to dependent children, AIDS (Disease), Alternative energy sources, Animals, Appropriations, Armed forces, Armed forces abroad, Armed forces reserves, Auditing Latest Action: 03/14/2008 - S.AMDT.4380 Amendment SA 4380 agreed to in Senate by Yea-Nay Vote. 41 - 57. Record Vote Number: 79.
Bill TextAn original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2009 and including the appropriate budgetary levels for fiscal years 2008 and 2010 through 2013. 3/14/2008--Passed Senate amended. (There are 2 other summaries) Sets forth the congressional budget for the federal government for FY2009, including the appropriate budgetary levels for FY2008 and FY2010-FY2013. Title I: Recommended Levels and Amounts - (Sec. 101) Lists recommended budgetary levels and amounts, for FY2008-FY2013, with respect to: (1) federal revenues; (2) new budget authority; (3) budget outlays; (4) deficits; (5) public debt; and (6) debt held by the public. (Sec. 102) Lists the appropriate levels of new budget authority, outlays, and administrative expenses for Social Security, U.S. Postal Service discretionary administrative expenses, and specified major functional categories for FY2008-FY2013.[...] show full description | | Also tagged in: Administrative procedure, Business, Congress, Congressional reporting requirements, Consumer education, Consumers, Deceptive advertising, Department of Health and Human Services, Drug adulteration, Drug industry, Drugs, Executive departments, Labeling, Law, Medical care, Medicine Latest Action: 11/06/2007 - Referred to the House Committee on Energy and Commerce.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration's authority to regulate drug advertising, and for other purposes. 11/6/2007--Introduced. Non-Prescription Drug Modernization Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to authorize: (1) the amendment or repeal of an over-the-counter drug monograph without notice and public procedure if there is a finding by the Secretary of Health and Human Services that a category of drugs or a specific drug is associated with a significant risk or that such drugs lack evidence of effectiveness; and (2) the Food and Drug Administration (FDA) to regulate over-the-counter drug advertisements. Directs the Commissioner of Food and Drugs to identify over-the-counter drug monographs that may require amendment or repeal and to report the findings to Congress. | | Also tagged in: Administrative procedure, Business, Congress, Congressional reporting requirements, Consumer education, Consumers, Deceptive advertising, Department of Health and Human Services, Drug adulteration, Drug industry, Drugs, Executive departments, Labeling, Law, Medical care, Medicine Latest Action: 11/06/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Bill TextA bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration's authority to regulate drug advertising, and for other purposes. 11/6/2007--Introduced. Non-Prescription Drug Modernization Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to authorize: (1) the amendment or repeal of an over-the-counter drug monograph without notice and public procedure if there is a finding by the Secretary of Health and Human Services that a category of drugs or a specific drug is associated with a significant risk or that such drugs lack evidence of effectiveness; and (2) the Food and Drug Administration (FDA) to regulate over-the-counter drug advertisements. Directs the Commissioner of Food and Drugs to identify over-the-counter drug monographs that may require amendment or repeal and to report the findings to Congress. | | Latest Action: 10/09/2007 - Referred to the Subcommittee on Health.
Bill TextTo direct the Commissioner of Food and Drugs to revise the Federal regulations applicable to the declaration of the trans fat content of a food on the label and in the labeling of the food when such content is less than 0.5 gram. 10/9/2007--Introduced. Trans Fat Truth in Labeling Act of 2007 - Directs the Commissioner of Food and Drugs to promulgate a final regulation revising federal regulations applicable to the declaration of the trans fat content on a food label to require that if the trans fat content of a serving of a food is less than .5 grams and is declared in the nutrition information on the label or in the labeling of the food, such content shall be expressed through the use of an asterisk or other notation stating that such content is less than .5 grams (instead of zero). | | Also tagged in: Administrative remedies, Clinical trials, Congress, Data banks, Department of Health and Human Services, Drug approvals, Executive departments, Health information systems, House rules and procedure, Law, Legislation, Medical care, Medical instruments and apparatus, Medicine, Technology Latest Action: 11/08/2007 - Referred to the Subcommittee on Health.
Bill TextTo correct technical errors in the enrollment of the bill H.R. 3580. 9/25/2007--Passed House without amendment. (There is 1 other summary) (This measure has not been amended since it was introduced. The summary of that version is repeated here.) Makes corrections in the enrollment of H.R. 3580 (Food and Drug Administration Amendments Act of 2007): (1) to include devices as well as drugs within the scope of provisions regarding an expanded clinical trial registry data bank; and (2) to require that consideration of a citizen petition or a petition for stay of agency action be made separately from review and approval of any application. | | Also tagged in: Administrative fees, Budgets, Business, Carbon monoxide, Consumer protection, Consumers, Deceptive advertising, Department of Health and Human Services, Drugs, Executive departments, Executive reorganization, Fines (Penalties), Food, Food additives, Food industry, Food labeling Latest Action: 09/26/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of food and drugs imported into the United States, and for other purposes. 9/20/2007--Introduced. Food and Drug Import Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to provide for research on the development of tests and sampling methodologies for use on imported food.Requires the Secretary to assess and collect fees on imported food and drugs.Directs the Secretary to restrict the importation of all food to metropolitan ports of entry with a Food and Drug Administration (FDA) laboratory for testing such food. Deems a food, drug, or device to be misbranded it its labeling fails to identify its country of origin. Requires the Secretary to establish a program under which: (1) persons importing food voluntarily agree to abide by specified food and security guidelines; and (2) the Secretary agrees to [...] show full description | | Also tagged in: Access to health care, Administrative fees, Administrative procedure, Administrative remedies, Agriculture, Animals, Antibiotics, Aquaculture, Authorization, Authors and authorship, Budgets, Business, Child health, Children, Civil liberties, Clinical trials Latest Action: 09/27/2007 - Signed by President.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. 9/27/2007--Public Law. (There is 1 other summary) (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential [...] show full description | | Also tagged in: Agricultural assistance, Agricultural colleges, Agricultural conservation, Agricultural credit, Agricultural education, Agricultural experiment stations, Agricultural extension work, Agricultural research, Agricultural statistics, Agricultural subsidies, Agriculture, Agriculture in foreign trade, Alien labor, Alternative energy sources, Animals, Apartment houses Latest Action: 08/03/2007 - Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 331.
Bill TextMaking appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2008, and for other purposes. 8/2/2007--Passed House amended. (There are 2 other summaries) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008 - Title I: Agricultural Programs - Appropriates FY2008 funds for the following Department of Agriculture (Department) programs and services: (1) Office of the Secretary of Agriculture (Secretary); (2) executive operations; (3) National Appeals Division; (4) Office of Budget and Program Analysis; (5) Homeland Security Staff; (6) Office of the Chief Information Officer; (7) Office of the Chief Financial Officer; (8) Office of the Assistant Secretary for Civil Rights; (9) Office of Civil Rights; (10) Office of the Assistant Secretary for Administration; (11) agriculture buildings and facilities [...] show full description | | Also tagged in: Actions and defenses, Administrative procedure, Agriculture, Agriculture in foreign trade, Budgets, Consumers, Criminal justice, Department of Agriculture, Department of Health and Human Services, Executive departments, Fines (Penalties), Food, Food safety, Import restrictions, Labeling, Law Latest Action: 07/11/2007 - Sponsor introductory remarks on measure. (CR H7636-7637)
Bill TextTo require the Secretary of Agriculture and the Commissioner of Food and Drugs to establish a program requiring a certificate of assured safety for imported food items. 7/11/2007--Introduced. Assured Food Safety Act of 2007 - Directs the Secretary of Agriculture and the Commissioner of Food and Drugs to jointly establish a program to require all food items imported into the United States to bear a certificate of assured safety issued by the government of the country from which the item is imported. Directs the Secretary and the Commissioner to: (1) establish certificate requirements; and (2) prohibit a food item that does not bear such certificate from being imported into the United States. Authorizes specified exemptions. Directs the Secretary and the Commissioner, upon a food item's failure to provide the assured safety level, to prohibit the importation of any similar food item produced by the same person in the same country until the Secretary or the Commissioner [...] show full description | | Also tagged in: Access to health care, Administrative fees, Administrative procedure, Administrative remedies, Animals, Antibiotics, Authorization, Budgets, Business, Cancer, Child health, Children, Civil liberties, Clinical trials, Communications, Computer security measures Latest Action: 07/16/2007 - Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 270.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. 7/11/2007--Passed House amended. (There is 1 other summary) Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety problems; (2) implementing and enforcing provisions relating to postapproval studies, clinical trials, labeling changes, and risk [...] show full description | | Also tagged in: Administration of justice, Administrative remedies, Afghanistan, Aged, Agriculture, Air force, Air pollution, Alaska, Alcohol tax, Alternative energy sources, American Battle Monuments Commission, Appalachian Regional Commission, Appellate courts, Appropriations, Arabs, Architect of the Capitol Latest Action: 12/26/2007 - Signed by President.
Bill TextMaking appropriations for the Department of State, foreign operations, and related programs for the fiscal year ending September 30, 2008, and for other purposes. 12/26/2007--Public Law. (There are 3 other summaries) Consolidated Appropriations Act, 2008 - Division A: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008 - Title I: Agricultural Programs - Appropriates FY2008 funds for the following Department of Agriculture (Department) programs and services: (1) Office of the Secretary of Agriculture (Secretary); (2) Office of the Chief Economist; (3) National Appeals Division; (4) Office of Budget and Program Analysis; (5) Homeland Security Staff; (6) Office of the Chief Information Officer; (7) Office of the Chief Financial Officer; (8) Office of the Assistant Secretary for [...] show full description | | Also tagged in: Administrative procedure, Appropriations, Authorization, Budgets, Business, Congress, Congressional reporting requirements, Consumer education, Consumer protection, Consumers, Deceptive advertising, Department of Health and Human Services, Dietary supplements, Executive departments, Federal aid to research, Federal employees Latest Action: 06/14/2007 - Referred to the Subcommittee on Health.
Bill TextTo ensure that the goals of the Dietary Supplement Health and Education Act of 1994 are met by authorizing appropriations to fully enforce and implement such Act and the amendments made by such Act, and for other purposes. 6/14/2007--Introduced. DSHEA Full Implementation and Enforcement Act of 2007 - Authorizes and makes appropriations to: (1) carry out the Dietary Supplement Health and Education Act of 1994 (DSHEA) and all applicable regulatory requirements for dietary supplements under the Federal Food, Drug, and Cosmetic Act; and (2) expand research and development of consumer information on dietary supplements by the Office of Dietary Supplements at the National Institutes of Health (NIH). Requires the Food and Drug Administration (FDA) to fully and appropriately use such funds to regulate dietary supplements. Directs the Secretary of Health and Human Services to report to Congress on the implementation and enforcement of DSHEA. | | Also tagged in: Administrative remedies, Business, Child health, Children, Clinical trials, Congress, Congressional investigations, Consumers, Department of Health and Human Services, Drug approvals, Drug industry, Drugs, Executive departments, Government information, Government paperwork, Government publicity Latest Action: 06/06/2007 - Referred to the House Committee on Energy and Commerce.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize and amend the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. 6/6/2007--Introduced. Improving Pharmaceuticals for Children Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions relating to market exclusivity for pediatric drug studies on new or already approved drugs to: (1) require that appropriate labeling changes are timely made; and (2) prohibit the Secretary of Health and Human Services from extending the period of market exclusivity later than one year prior to the expiration of such period. Directs the Secretary to: (1) publish a notice identifying any drug for which a pediatric formulation was developed, studied, and found to be safe and effective in the pediatric population if such formulation is not introduced onto the market within one year; and (2) order the labeling of a drug to include information [...] show full description | | Also tagged in: Administrative procedure, Child health, Children, Communication in medicine, Communication in science, Communications, Conferences, Consumer education, Consumers, Contraceptives, Department of Health and Human Services, Executive departments, Executive reorganization, Hazardous substances, Health policy, Ionizing radiation Latest Action: 05/24/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act with respect to the Office of Women's Health and the regulation of breast implants, and to provide for a scientific workshop on the use of emergency contraception by women under age 18. 5/24/2007--Introduced. FDA Scientific Fairness for Women Act - Amends the Federal Food, Drug, and Cosmetic Act to establish the Office of Women's Health within the Office of the Commissioner of the Food and Drug Administration (FDA). Deems a breast implant to be a class III medical device. Requires premarket approval of breast implants irrespective of whether the implant has been cleared for commercial distribution in interstate commerce before the date of enactment of this Act.Prohibits the Secretary of Health and Human Services from finding that a reasonable assurance of safety has been shown for an application for premarket approval for a a breast implant unless the applicant involved has demonstrated its safety for the life [...] show full description | | Also tagged in: Administrative fees, Animals, Budgets, Business, Clinical trials, Communication in medicine, Communications, Conflict of interests, Consumer education, Consumer protection, Consumers, Data banks, Department of Health and Human Services, Drug advertising, Drug approvals, Drug industry Latest Action: 05/10/2007 - Referred to the House Committee on Energy and Commerce.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act to provide for the deposit in the general fund of the Treasury of fees that are collected from manufacturers of drugs and devices under chapter VII of such Act, to terminate the authority of the Food and Drug Administration to negotiate with the manufacturers on particular uses of the fees, to establish a Center for Postmarket Drug Safety and Effectiveness, to establish additional authorities to ensure the safe and effective use of drugs, and for other purposes. 5/10/2007--Introduced. Food and Drug Administration Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, and animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services to review such applications. Prohibits the Secretary from entering into agreements with persons [...] show full description | | Also tagged in: Animals, Business, Consumer education, Consumers, Defective products, Department of Health and Human Services, Executive departments, Food, Food industry, Food safety, Foodborne diseases, Government information, Government publicity, Health warnings, Imports, Labeling Latest Action: 05/02/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of food for humans and pets. 5/2/2007--Introduced. Human and Pet Food Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a person that has reason to believe that any food introduced into interstate commerce may be in violation of the FFDCA to immediately notify the Secretary of the Health and Human Services of the identity and location of the food.Requires the Secretary, upon a determination that such food is in violation of the FFDCA and that there is a reasonable probability that the food, if consumed, would present a threat to the public health, to give appropriate persons an opportunity to: (1) cease distribution of the food; (2) notify all relevant persons to cease distribution of the food; (3) recall the food; and (4) provide notice to consumers and public health officials. Authorizes the Secretary to control and possess the food and to order the person [...] show full description | | Also tagged in: Animals, Business, Consumer education, Consumers, Defective products, Department of Health and Human Services, Executive departments, Food, Food industry, Food safety, Foodborne diseases, Government information, Government publicity, Health warnings, Imports, Labeling Latest Action: 05/02/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S5508-5510)
Bill TextA bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of food for humans and pets. 5/2/2007--Introduced. Human and Pet Food Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a person that has reason to believe that any food introduced into interstate commerce may be in violation of the FFDCA to immediately notify the Secretary of the Health and Human Services of the identity and location of the food.Requires the Secretary, upon a determination that such food is in violation of the FFDCA and that there is a reasonable probability that the food, if consumed, would present a threat to the public health, to give appropriate persons an opportunity to: (1) cease distribution of the food; (2) notify all relevant persons to cease distribution of the food; (3) recall the food; and (4) provide notice to consumers and public health officials. Authorizes the Secretary to control and possess the food and to order [...] show full description | | Also tagged in: Administrative procedure, Administrative remedies, Congressional reporting requirements, Consumer education, Consumer protection, Consumers, Cosmetics, Defective products, Department of Health and Human Services, Drugs, Electronics, Executive departments, Food, Food safety, Governmental investigations, Law Latest Action: 05/01/2007 - Referred to the Subcommittee on Commerce, Trade and Consumer Protection.
Bill TextTo authorize the Secretary of Health and Human Services to order a mandatory recall of any product that is regulated by the Food and Drug Administration, and for other purposes. 5/1/2007--Introduced. Protect Consumers Act of 2007 - Requires the Secretary of Health and Human Services, upon a determination that it is necessary to implement a mandatory recall of any product regulated by the Food and Drug Administration (FDA), to issue an order requiring the appropriate person to: (1) immediately cease distribution, manufacture, and sale of such product; (2) immediately provide notice to individuals subject to the risks associated with the use of such product; and (3) implement an immediate recall of such product. Directs that the order shall provide for an informal hearing within ten days. Treats the failure to obey such an order as a prohibited act under the Federal Food, Drug, and Cosmetic Act. Requires the Secretary to study and implement new procedures [...] show full description | | Also tagged in: Access to health care, Aged, AIDS (Disease), Alaska, American studies, Asian American ethnic groups, Black colleges, Boundaries, Budgets, Building construction, Cancer, Centers for Disease Control and Prevention (CDC), Child health, Children, Civil rights, Civil rights enforcement Latest Action: 09/11/2007 - Referred to the Subcommittee on Early Childhood, Elementary, and Secondary Education.
Bill TextTo improve the health of minority individuals, and for other purposes. 7/12/2007--Introduced. Health Equity and Accountability Act of 2007 - Amends the Public Health Service Act to require the Secretary of Health and Human Services to establish the Robert T. Matsui Center for Cultural and Linguistic Competence in Health Care.Provides for health care workforce diversity activities, including the establishment of: (1) a technical clearinghouse on health workforce diversity; and (2) Regional Minority Centers of Excellence Programs.Requires health-related programs of the Department of Health and Human Services (HHS) to collect data on race, ethnicity, and primary language.Directs each federal health agency to implement a strategic plan to eliminate disparities and improve the health and health care of minority populations. Requires the Secretary to establish: (1) an Office of Health Disparities within the Office of Civil Rights; and (2) civil rights [...] show full description | | Also tagged in: Abortion, Actions and defenses, Administrative fees, Administrative procedure, Agriculture, Agriculture in foreign trade, Animals, Antibiotics, Biomedical engineering, Budgets, Business, Canada, Cancer, Chemotherapy, Child health, Children Latest Action: 05/10/2007 - Received in the House.
Bill TextAn act to amend the Federal Food, Drug, and cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes. 5/9/2007--Passed Senate amended. (There are 2 other summaries) Food and Drug Administration Revitalization Act - Title I: Prescription Drug User Fees - (Sec. 101) - Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth as a purpose that authorized prescription drug fees be dedicated toward expediting the drug development process, the process for the review of human drug applications, and postmarket drug safety. Sets forth reporting requirements, including requiring the Secretary of Human Services (the Secretary) to present to Congress recommendations developed for achieving certain goals for the review process of human drug applications and for reauthorization of user [...] show full description | | Also tagged in: Affordable housing, Afghanistan, Aged, Agricultural subsidies, Agriculture, Alcohol as fuel, Alien labor, Alternative energy sources, Appropriations, Armed forces, Armed forces abroad, Authorization, Border patrols, Budget deficits, Budget reconciliation, Budget resolutions Latest Action: 05/17/2007 - Conference papers: Senate report and manager's statement and message on House action held at the desk in Senate.
Bill TextAn original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2008 and including the appropriate budgetary levels for fiscal years 2007 and 2009 through 2012. 5/16/2007--Conference report filed in House. (There are 4 other summaries) Sets forth the congressional budget for the federal government for FY2008, including the appropriate budgetary levels for FY2007 and FY2009-FY2012. Title I: Recommended Levels and Amounts - (Sec. 101) Lists recommended budgetary levels and amounts, for FY2007-FY2012, with respect to: (1) federal revenues; (2) new budget authority; (3) budget outlays; (4) deficits; (5) debt subject to limit; and (6) debt held by the public. (Sec. 102) Lists the appropriate levels of new budget authority, outlays, and administrative expenses for Social Security and specified major functional categories for FY2007-FY2012. Title II: Budget Process [...] show full description | | Also tagged in: Biomedical engineering, Budgets, Business, Business records, Child health, Children, Congress, Congressional investigations, Congressional reporting requirements, Consumers, Data banks, Department of Health and Human Services, Electronic data interchange, Executive departments, Federal advisory bodies, Government information Latest Action: 03/14/2007 - Referred to the Subcommittee on Health.
Bill TextTo improve the process for the development of needed pediatric medical devices. 3/13/2007--Introduced. Pediatric Medical Device Safety and Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for the approval of a medical device or a product development protocol to include: (1) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (2) the number of affected pediatric patients. Excludes a medical device distributed pursuant to the humanitarian device exemption from the prohibition that no device be sold for an amount that exceeds the cost of the device if: (1) the device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients; and (2) other specified requirements are met. Requires the Director of the National Institutes of Health (NIH) to designate a contact point to help innovators [...] show full description | | Also tagged in: Administrative procedure, Antibiotics, Biotechnology, Business, Clinical trials, Communicable diseases, Congressional reporting requirements, Department of Health and Human Services, Drug approvals, Drug industry, Drug resistance in microorganisms, Executive departments, Executive reorganization, Federal advisory bodies, Government information, Government paperwork Latest Action: 04/20/2007 - Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
Bill TextTo provide incentives for pharmaceutical companies, biotechnology companies, and medical device companies to invest in research and development with respect to antibiotic drugs, antivirals, diagnostic tests, and vaccines that may be used to identify, treat, or prevent serious and life-threatening infectious diseases. 3/13/2007--Introduced. Beating Infections through Research and Development Act of 2007 - Sets forth circumstances under which the term of a patent may be extended for qualified infectious disease products.Requires the Secretary of Health and Human Services to designate qualified infectious disease products as fast-track products for approval.Amends the Public Health Service Act to require the Director of the National Institute of Allergy and Infectious Diseases to expand and intensify efforts to assist small manufacturers to conduct end-stage clinical trials on qualified infectious disease products.Amends the Internal Revenue Code to establish [...] show full description | | Also tagged in: Biomedical engineering, Budgets, Business, Business records, Child health, Children, Congress, Congressional investigations, Congressional reporting requirements, Consumers, Data banks, Department of Health and Human Services, Electronic data interchange, Executive departments, Federal advisory bodies, Government information Latest Action: 03/08/2007 - Sponsor introductory remarks on measure. (CR S2920-2921)
Bill TextA bill to improve the process for the development of needed pediatric medical devices. 3/8/2007--Introduced. Pediatric Medical Device Safety and Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for the approval of a medical device or a product development protocol to include: (1) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (2) the number of affected pediatric patients. Excludes a medical device distributed pursuant to the humanitarian device exemption from the prohibition that no device be sold for an amount that exceeds the cost of the device if: (1) the device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients; and (2) other specified requirements are met. Requires the Director of the National Institutes of Health (NIH) to designate a contact point to help [...] show full description | | Also tagged in: Administrative procedure, Blood tests, Consumers, Data banks, Department of Health and Human Services, Electronic data interchange, Executive departments, Genetics, Government information, Government paperwork, Government publicity, Internet, Labeling, Law, Medical care, Medical instruments and apparatus Latest Action: 03/01/2007 - Sponsor introductory remarks on measure. (CR S2502-2503)
Bill TextA bill to provide for the regulation and oversight of laboratory tests. 3/1/2007--Introduced. Laboratory Test Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a laboratory-developed test that is a direct-to-consumer test to be a prescription test if it satisfies the requirements of this Act. Deems any laboratory-developed test to be a medical device.Sets forth labeling and registration requirements for laboratory-developed tests.Requires the manufacturer of a laboratory-developed test that has not been cleared or approved for its intended use to submit the analytical and clinical validity of the test for its intended use to the Secretary of Health and Human Services. Requires the Secretary to include such information in a public database.Requires the Secretary to provide guidance to: (1) facilitate the use of reviews of the peer-reviewed biomedical literature and other information and data about the clinical validity [...] show full description | | Also tagged in: Administrative procedure, Agricultural conservation, Agricultural credit, Agricultural extension work, Agricultural research, Agricultural subsidies, Agriculture in foreign trade, Animals, Appropriations, Budgets, Business, Child nutrition, Children, Communications, Congress, Congressional reporting requirements Latest Action: 07/24/2007 - Committee on Appropriations. Original measure reported to Senate by Senator Kohl. With written report No. 110-134.
Bill TextAn original bill making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2008, and for other purposes. 7/24/2007--Reported to Senate without amendment. (There is 1 other summary) (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008 - Title I: Agricultural Programs - Appropriates FY2008 funds for the following Department of Agriculture (Department) programs and services: (1) Office of the Secretary of Agriculture (Secretary); (2) executive operations; (3) National Appeals Division; (4) Office of Budget and Program Analysis; (5) Homeland Security Staff; (6) Office of the Chief Information Officer; (7) Office of the Chief Financial Officer; (8) Office [...] show full description | | Also tagged in: Actions and defenses, Administrative procedure, Administrative remedies, Advice and consent of the Senate, Agricultural extension work, Agricultural research, Agriculture, Agriculture in foreign trade, Animal diseases, Animals, Antibiotics, Armed forces, Auditing, Biological warfare, Bribery, Business Latest Action: 02/27/2007 - Referred to the Subcommittee on Health.
Bill TextTo establish the Food Safety Administration to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination, and for other purposes. 2/16/2007--Introduced. Safe Food Act of 2007 - Establishes the Food Safety Administration to administer and enforce food safety laws. Directs the Administrator of the Food Safety Administration to: (1) promulgate regulations to ensure the security of the food supply from all forms of contamination; (2) implement federal food safety inspection, enforcement, and research efforts to protect the public health; (3) develop consistent and science-based standards for safe food; and (4) prioritize federal food safety efforts and deployment of resources to achieve the greatest possible benefit in reducing food-borne illness. Transfers to the Administration all functions of specified federal [...] show full description | | Also tagged in: Actions and defenses, Administrative remedies, Budgets, Business, Censorship, Civil liberties, Civil rights, Communication in medicine, Communication in science, Communications, Congressional reporting requirements, Consumers, Criminal justice, Criminal justice information, Damages, Deceptive advertising Latest Action: 02/27/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities to ensure the safe and effective use of drugs, to establish whistleblower protections for certain individuals, and for other purposes. 2/16/2007--Introduced. Swift Approval, Full Evaluation Drug Act or the SAFE Drug Act - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services to: (1) order postmarket studies of approved drugs upon receiving evidence of a significant issue regarding the safety or lack of effectiveness of such a drug; and (2) establish restrictions on the distribution or use of the drug during the period in which the study is conducted.Directs the Secretary to amend regulations to require postmarket studies of drugs approved under an accelerated approval process for new drugs for serious or life-threatening illnesses. Deems a drug or device to be misbranded if there is a failure to comply with requirements under [...] show full description | | Also tagged in: Access to health care, Centers for Disease Control and Prevention (CDC), Clinical trials, Communication in medicine, Communications, Congress, Congressional oversight, Congressional reporting requirements, Department of Health and Human Services, Drug abuse, Drug abuse prevention, Drug abuse treatment, Drug approvals, Education, Executive departments, Executive reorganization Latest Action: 02/16/2007 - Referred to the Subcommittee on Health.
Bill TextTo improve the health of women through the establishment of Offices of Women's Health within the Department of Health and Human Services. 2/15/2007--Introduced. Women's Health Office Act of 2007 - Amends the Public Health Service Act to establish an Office on Women's Health within the Office of the Secretary of Health and Human Services. Requires the Secretary, acting through the Director of the Office, to establish: (1) a Department of Health and Human Services Coordinating Committee on Women's Health; and (2) a National Women's Health Information Center. Transfers the functions of the Office on Women's Health of the Public of Health Service to the Office on Women's Health within the Department of Health and Human Services (HHS). Amends the Public Health Service Act, the Social Security Act, and the Federal Food, Drug, and Cosmetic Act to establish separate Offices of Women's Health within the Office of the Director of the Centers for Disease Control and Prevention [...] show full description | | Also tagged in: Access to health care, Centers for Disease Control and Prevention (CDC), Clinical trials, Communication in medicine, Communications, Congress, Congressional oversight, Congressional reporting requirements, Department of Health and Human Services, Drug abuse, Drug abuse prevention, Drug abuse treatment, Drug approvals, Education, Executive departments, Executive reorganization Latest Action: 02/15/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Bill TextA bill to improve the health of women through the establishment of Offices of Women's Health within the Department of Health and Human Services. 2/15/2007--Introduced. Women's Health Office Act of 2007 - Amends the Public Health Service Act to establish an Office on Women's Health within the Office of the Secretary of Health and Human Services. Requires the Secretary, acting through the Director of the Office, to establish: (1) a Department of Health and Human Services Coordinating Committee on Women's Health; and (2) a National Women's Health Information Center. Transfers the functions of the Office on Women's Health of the Public of Health Service to the Office on Women's Health within the Department of Health and Human Services (HHS). Amends the Public Health Service Act, the Social Security Act, and the Federal Food, Drug, and Cosmetic Act to establish separate Offices of Women's Health within the Office of the Director of the Centers for Disease Control and Prevention [...] show full description | | Also tagged in: Actions and defenses, Administrative remedies, Business, Clinical trials, Congressional reporting requirements, Consumers, Department of Health and Human Services, Drug approvals, Drug industry, Executive departments, Injunctions, Intellectual property, Judicial opinions, Judicial review, Labeling, Law Latest Action: 02/27/2007 - Star Print ordered on S. 623.
Bill TextA bill to amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. 2/15/2007--Introduced. Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of an abbreviated biological product application for products that contain the same or similar active ingredients as a previously licensed biological product (the reference product). Allows a person to file an abbreviated biological product application with the Secretary of Health and Human Services that includes: (1) data demonstrating that the product is comparable to or interchangeable with the reference product; (2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; and (3) information to show that the route of administration, the [...] show full description | | Also tagged in: Administrative procedure, Administrative remedies, Advertising, Agriculture, Budgets, Business, Business records, Cancer, Carcinogens, Cardiovascular diseases, Chemicals, Child health, Children, Cigarettes, Civil liberties, Communications Latest Action: 04/02/2008 - Committee Consideration and Mark-up Session Held.
Bill TextTo protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products. 2/15/2007--Introduced. Family Smoking Prevention and Tobacco Control Act - Amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of tobacco products by the Secretary of Health and Human Services through the Food and Drug Administration, including through disclosure, annual registration, inspection, recordkeeping, and user fee requirements. Sets forth criteria by which tobacco products are deemed adulterated or misbranded. Allows the Secretary to require prior approval of all label statements. Allows the Secretary to restrict the sale or distribution of tobacco products, including advertising and promotion, if the Secretary determines that such regulation would be appropriate for the protection of the public health. Prohibits such regulations from: (1) limiting product sales or distribution to authorization [...] show full description | | Also tagged in: Administrative procedure, Administrative remedies, Advertising, Agriculture, Budgets, Business, Business records, Cancer, Carcinogens, Cardiovascular diseases, Chemicals, Child health, Children, Cigarettes, Civil liberties, Communications Latest Action: 08/01/2007 - Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Bill TextA bill to protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products. 2/15/2007--Introduced. Family Smoking Prevention and Tobacco Control Act - Amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of tobacco products by the Secretary of Health and Human Services through the Food and Drug Administration, including through disclosure, annual registration, inspection, recordkeeping, and user fee requirements. Sets forth criteria by which tobacco products are deemed adulterated or misbranded. Allows the Secretary to require prior approval of all label statements. Allows the Secretary to restrict the sale or distribution of tobacco products, including advertising and promotion, if the Secretary determines that such regulation would be appropriate for the protection of the public health. Prohibits such regulations from: (1) limiting product sales or distribution to authorization [...] show full description | | Also tagged in: Actions and defenses, Administrative procedure, Administrative remedies, Advice and consent of the Senate, Agricultural extension work, Agricultural research, Agriculture, Agriculture in foreign trade, Animal diseases, Animals, Antibiotics, Armed forces, Auditing, Biological warfare, Bribery, Business Latest Action: 02/15/2007 - Sponsor introductory remarks on measure. (CR S2101)
Bill TextA bill to establish the Food Safety Administration to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination, and for other purposes. 2/15/2007--Introduced. Safe Food Act of 2007 - Establishes the Food Safety Administration to administer and enforce food safety laws. Directs the Administrator of the Food Safety Administration to: (1) promulgate regulations to ensure the security of the food supply from all forms of contamination; (2) implement federal food safety inspection, enforcement, and research efforts to protect the public health; (3) develop consistent and science-based standards for safe food; and (4) prioritize federal food safety efforts and deployment of resources to achieve the greatest possible benefit in reducing food-borne illness. Transfers to the Administration all functions of specified federal [...] show full description | | Also tagged in: Actions and defenses, Administrative remedies, Business, Clinical trials, Congressional reporting requirements, Consumers, Department of Health and Human Services, Drug approvals, Drug industry, Executive departments, Injunctions, Intellectual property, Judicial opinions, Judicial review, Labeling, Law Latest Action: 02/15/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. 2/14/2007--Introduced. Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of an abbreviated biological product application for products that contain the same or similar active ingredients as a previously licensed biological product (the reference product). Allows a person to file an abbreviated biological product application with the Secretary of Health and Human Services that includes: (1) data demonstrating that the product is comparable to or interchangeable with the reference product; (2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; and (3) information to show that the route of administration, the dosage [...] show full description | | Also tagged in: Access to health care, Administrative procedure, Aged, Business, Cardiovascular diseases, Clinical trials, Communication in medicine, Communication in science, Congress, Congressional investigations, Congressional reporting requirements, Data banks, Department of Health and Human Services, Drug approvals, Drug industry, Drugs Latest Action: 02/13/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Bill TextA bill to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. 2/13/2007--Introduced. Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - Amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to require an application for approval or for investigation of a drug, device, or biological product to include information stratified by sex, race, and ethnicity, including any differences in safety and effectiveness. Requires the Secretary of Health and Human Services to: (1) withhold approval of such an application or place a clinical hold on an investigation if such information is not included; and (2) report to the scientific community and make information available to the public on such stratified data upon approval of an application.Requires the Comptroller [...] show full description | | Also tagged in: Access to health care, Administrative procedure, Aged, Business, Cardiovascular diseases, Clinical trials, Communication in medicine, Communication in science, Congress, Congressional investigations, Congressional reporting requirements, Data banks, Department of Health and Human Services, Drug approvals, Drug industry, Drugs Latest Action: 05/01/2007 - Subcommittee Consideration and Mark-up Session Held.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. 2/13/2007--Introduced. Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - Amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to require an application for approval or for investigation of a drug, device, or biological product to include information stratified by sex, race, and ethnicity, including any differences in safety and effectiveness. Requires the Secretary of Health and Human Services to: (1) withhold approval of such an application or place a clinical hold on an investigation if such information is not included; and (2) report to the scientific community and make information available to the public on such stratified data upon approval of an application.Requires the Comptroller [...] show full description | | Also tagged in: Accreditation (Medical care), Actions and defenses, Administrative fees, Administrative procedure, Administrative remedies, Aged, Appropriations, Armed forces, Auditing, Australia, Budgets, Business, Business records, Canada, Capital gains tax, Caribbean area Latest Action: 02/12/2007 - Sponsor introductory remarks on measure. (CR S1855-1857)
Bill TextA bill to reduce the Federal budget deficit, and for other purposes. 2/12/2007--Introduced. Act for Our Kids - Repeals the Television Broadcasting to Cuba Act. Amends the Cuban Liberty and Democratic Solidarity (LIBERTAD) Act of 1996 to prohibit federal funding of television broadcasting to Cuba. Terminates the U.S. Court of Federal Claims. Requires federal agencies to reduce administrative expenses. Eliminates the Medicare Advantage Regional Plan Stabilization (SLUSH) Fund. Amends the federal criminal code to prohibit profiteering and fraud involving a contract or the provision of goods or services in connection with a war or military action. Requires: (1) suspension and debarment of unethical contractors; (2) disclosure by federal agencies, upon request, to the appropriate committee chairman or ranking member of audit reports regarding federal contractors; and (3) public access to information on federal contractor penalties and [...] show full description | | Also tagged in: Administrative procedure, Agriculture, Business, Consumers, Dairy industry, Dairy products, Department of Health and Human Services, Executive departments, Farmers, Food, Food labeling, Law, Milk, Proteins Latest Action: 02/08/2007 - Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry. (text of measure as introduced: CR S1786)
Bill TextA bill to prohibit products that contain dry ultra-filtered milk products, milk protein concentrate, or casein from being labeled as domestic natural cheese, and for other purposes. 2/8/2007--Introduced. Quality Cheese Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit the Commissioner of the Food and Drug Administration from using federal funds to amend specified regulations to include dry ultra-filtered milk, milk protein concentrate, or casein in the definition of "milk" or "nonfat milk" as specified in the domestic natural standards for cheese and cheese products. | | Also tagged in: Administrative remedies, Animal diseases, Animals, Consumer education, Consumers, Department of Health and Human Services, Executive departments, Government information, Government paperwork, Law, Medical care, Medicine, Pets, Preventive medicine, Retail trade, Salmonella Latest Action: 02/09/2007 - Referred to the Subcommittee on Health.
Bill TextTo require the Food and Drug Administration to permit the sale of baby turtles as pets so long as the seller uses proven methods to effectively treat salmonella. 2/8/2007--Introduced. Domestic Pet Turtle Market Access Act of 2007 - Prohibits the Food and Drug Administration (FDA) from restricting the sale by a turtle farmer or other commercial retail seller of a turtle that is less than 10.2 centimeters in diameter as a pet if: (1) the turtle is raised, shipped, and sold using methods proven to keep the turtle free of salmonella, using salmonella safety standards comparable to standards for other animals allowed for sale as pets or animal products allowed for sale as food products; (2) the FDA has approved a plan submitted by the turtle farmer or seller relating to compliance with this Act; and (3) the farmer or seller makes certain disclosures to the buyer. Sets forth required disclosures, which include: (1) information regarding the dangers that could result if the turtle [...] show full description | | Also tagged in: Administrative remedies, Animal diseases, Animals, Consumer education, Consumers, Department of Health and Human Services, Executive departments, Government information, Government paperwork, Law, Medical care, Medicine, Pets, Preventive medicine, Retail trade, Salmonella Latest Action: 02/08/2007 - Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry.
Bill TextA bill to require the Food and Drug Administration to permit the sale of baby turtles as pets so long as the seller uses proven methods to effectively treat salmonella. 2/8/2007--Introduced. Domestic Pet Turtle Market Access Act of 2007 - Prohibits the Food and Drug Administration (FDA) from restricting the sale by a turtle farmer or other commercial retail seller of a turtle that is less than 10.2 centimeters in diameter as a pet if: (1) the turtle is raised, shipped, and sold using methods proven to keep the turtle free of salmonella, using salmonella safety standards comparable to standards for other animals allowed for sale as pets or animal products allowed for sale as food products; (2) the FDA has approved a plan submitted by the turtle farmer or seller relating to compliance with this Act; and (3) the farmer or seller makes certain disclosures to the buyer. Sets forth required disclosures, which include: (1) information regarding the dangers that could result if the [...] show full description | | Also tagged in: Biomedical engineering, Business, Clinical trials, Conflict of interests, Congress, Congressional reporting requirements, Consumers, Corporations, Data banks, Department of Health and Human Services, Drug approvals, Drug industry, Drug interactions, Drug utilization, Drugs, Executive departments Latest Action: 03/14/2007 - Committee on Health, Education, Labor, and Pensions. Hearings held.
Bill TextA bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes. 2/1/2007--Introduced. Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug. Establishes a Drug Safety Oversight Board. Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product [...] show full description | | Also tagged in: Administrative remedies, Advertising, Biomedical engineering, Business, Clinical trials, Congress, Congressional reporting requirements, Consumer education, Consumers, Cost effectiveness, Data banks, Department of Health and Human Services, Drug adulteration, Drug approvals, Drug industry, Epidemiology Latest Action: 02/02/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. 1/31/2007--Introduced. Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics within the Food and Drug Administration (FDA). Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by: (1) conducting postmarket risk assessment and surveillance of such drugs and products; (2) determining whether a postmarket study is required; (3) contracting, or requiring the sponsor of such a drug or product to contract, with the holders of domestic and international patient databases to conduct epidemiologic and other observational studies; (4) determining whether a drug or product may present an unreasonable risk to the health of patients or the [...] show full description | | Also tagged in: Administrative remedies, Advertising, Biomedical engineering, Business, Clinical trials, Congress, Congressional reporting requirements, Consumer education, Consumers, Cost effectiveness, Data banks, Department of Health and Human Services, Drug adulteration, Drug approvals, Drug industry, Epidemiology Latest Action: 01/31/2007 - Sponsor introductory remarks on measure. (CR S1454-1455)
Bill TextA bill to amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. 1/31/2007--Introduced. Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics within the Food and Drug Administration (FDA). Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by: (1) conducting postmarket risk assessment and surveillance of such drugs and products; (2) determining whether a postmarket study is required; (3) contracting, or requiring the sponsor of such a drug or product to contract, with the holders of domestic and international patient databases to conduct epidemiologic and other observational studies; (4) determining whether a drug or product may present an unreasonable risk to the health of patients [...] show full description | | Also tagged in: Accreditation (Medical care), Actions and defenses, Administrative fees, Administrative procedure, Administrative remedies, Australia, Budgets, Business, Business records, Canada, Checks, Civil liberties, Congress, Congressional reporting requirements, Consumer education, Consumers Latest Action: 02/02/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes. 1/10/2007--Introduced. Pharmaceutical Market Access and Drug Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States. Prohibits the importation of a qualifying drug unless such drug is imported by: (1) a registered importer; or (2) an individual for personal use. Establishes registration conditions for importers and exporters. Requires the Secretary to inspect places of business, verify chains of custody, inspect facilities, and determine compliance with registration conditions. Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences.[...] show full description | | Also tagged in: Accreditation (Medical care), Actions and defenses, Administrative fees, Administrative procedure, Administrative remedies, Australia, Budgets, Business, Business records, Canada, Checks, Civil liberties, Congress, Congressional reporting requirements, Consumer education, Consumers Latest Action: 03/07/2007 - Committee on Commerce, Science, and Transportation Subcommittee on Interstate Commerce, Trade, and Tourism. Hearings held.
Bill TextA bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes. 1/10/2007--Introduced. Pharmaceutical Market Access and Drug Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States. Prohibits the importation of a qualifying drug unless such drug is imported by: (1) a registered importer; or (2) an individual for personal use. Establishes registration conditions for importers and exporters. Requires the Secretary to inspect places of business, verify chains of custody, inspect facilities, and determine compliance with registration conditions. Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences.[...] show full description | | Also tagged in: Administrative procedure, Administrative remedies, Business, Department of Health and Human Services, Drug approvals, Drug industry, Executive departments, Fines (Penalties), Governmental investigations, Law, Legal fees, Marketing, Medical care, Medicine Latest Action: 01/04/2007 - Sponsor introductory remarks on measure. (CR S64-65)
Bill TextA bill to amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes. 1/4/2007--Introduced. Citizen Petition Fairness and Accuracy Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require that any citizen petition or request for stay of action related to an abbreviated new drug application include a statement that to the petitioner's best knowledge and belief, the petition: (1) includes all information and views on which the petitioner relies; (2) is well grounded in fact and is warranted by law; (3) is not submitted for an improper purpose; and (4) does not contain a materially false, misleading, or fraudulent statement. Requires the Secretary of Health and Human Services to investigate any petition that does not comply with such requirements. Allows the Secretary to impose penalties for knowingly and willfully submitting a petition for an improper [...] show full description | | Also tagged in: Abortion, Administrative procedure, Congress, Congressional investigations, Congressional reporting requirements, Congressional veto, Consumers, Department of Health and Human Services, Drug approvals, Drugs, Executive departments, Government information, Government publicity, Labeling, Law, Medical care Latest Action: 02/02/2007 - Referred to the Subcommittee on Health.
Bill TextTo provide that the approved application under the Federal Food, Drug, and Cosmetic Act for the drug commonly known as RU-486 is deemed to have been withdrawn, to provide for the review by the Comptroller General of the United States of the process by which the Food and Drug Administration approved such drug, and for other purposes. 1/4/2007--Introduced. RU-486 Suspension and Review Act of 2007 - Deems the approved application for the drug mifepristone (marketed as Mifeprex, commonly known as RU-486, and used for the chemically induced termination of intrauterine pregnancy) to have been withdrawn. Deems the drug misoprostol to be misbranded under the Federal Food, Drug, and Cosmetic Act (FFDCA) if it bears labeling providing that the drug may be used for the medical termination of intrauterine pregnancy. Directs the Comptroller General to review and report on the process by which the Food and Drug Administration (FDA) approved mifepristone. Provides for the [...] show full description |
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