All Clinical trials Legislation - Federal Government
S.3409 - A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes.
Latest Action: 07/31/2008 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Bill Text A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes. Comment on Bill H.R.6568 - To direct the Secretary of Health and Human Services to encourage research and carry out an educational campaign with respect to pulmonary hypertension, and for other purposes.
Latest Action: 09/26/2008 - Received in the Senate. Bill Text To direct the Secretary of Health and Human Services to encourage research and carry out an educational campaign with respect to pulmonary hypertension, and for other purposes. 7/22/2008--Introduced. Tom Lantos Pulmonary Hypertension Research and Education Act of 2008 - Expresses the sense of the Congress that: (1) the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH) and the Director of the National Heart, Lung, and Blood Institute, should continue aggressive work on pulmonary hypertension; and (2) the Director of the Institute should continue research to expand the understanding of the causes of, and to find a cure for, pulmonary hypertension.Requires inclusion of information on the status of pulmonary hypertension research at NIH in biennial reports to Congress. Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to carry out an educational [...] show full description H.R.6432 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, to establish a program of fees relating to generic new animal drugs, to make certain technical corrections to the Food and Drug Administration Amendments Act of 2007, and for other purposes.
Latest Action: 08/14/2008 - Signed by President. Bill Text To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, to establish a program of fees relating to generic new animal drugs, to make certain technical corrections to the Food and Drug Administration Amendments Act of 2007, and for other purposes. 8/14/2008--Public Law. (There are 3 other summaries) (This measure has not been amended since it was passed by the House on July 30, 2008. The summary of that version is repeated here.) Title I: Animal Drug User Fee Amendments - Animal Drug User Fee Amendments of 2008 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act to revise definitions, including defining the "process for the review of animal drug applications" to include the review of advertising and labeling prior to an approval of an animal drug application or supplemental animal application after the animal drug has been approved.(Sec. 103) Requires the [...] show full description H.R.6331 - To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes.
Latest Action: 07/15/2008 - Vetoed by President. Bill Text To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. 7/15/2008--Public Law. (There are 3 other summaries) (This measure has not been amended since it was passed by the House on June 24, 2008. The summary of that version is repeated here.) Medicare Improvements for Patients and Providers Act of 2008 - Title I: Medicare - Subtitle A: Beneficiary Improvements - Part 1: Prevention, Mental Health, and Marketing - (Sec. 101) Amends title XVIII (Medicare) of the Social Security Act (SSA), as amended by the Medicare, Medicaid, and SCHIP Extension Act of 2007, to cover additional preventive services. Includes body mass index and end-of-life planning among initial [...] show full description H.R.6270 - To amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes.
Latest Action: 06/17/2008 - Referred to the Subcommittee on Health. Bill Text To amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes. 6/12/2008--Introduced. Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met.Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act. Establishes a procedure for accelerated approval of an investigational drug, biological product, or device [...] show full description S.3092 - A bill to amend the Public Health Service Act to ensure sufficient resources and increase efforts for research at the National Institutes of Health relating to Alzheimer's disease, to authorize an education and outreach program to promote public awareness and risk reduction with respect to Alzheimer's disease (with particular emphasis on education and outreach in Hispanic populations), and for other purposes.
Latest Action: 06/05/2008 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Bill Text A bill to amend the Public Health Service Act to ensure sufficient resources and increase efforts for research at the National Institutes of Health relating to Alzheimer's disease, to authorize an education and outreach program to promote public awareness and risk reduction with respect to Alzheimer's disease (with particular emphasis on education and outreach in Hispanic populations), and for other purposes. 6/5/2008--Introduced. Cure and Understanding through Research for Alzheimer's Act of 2008 or the Cura Act of 2008 - Requires the Director of the National Institutes of Health (NIH) to ensure sufficient resources for activities relating to Alzheimer's disease and Hispanic communities, including by: (1) increasing efforts in epidemiological work in Hispanic subgroups; (2) allocating resources to the National Institute on Aging Alzheimer's disease research centers and other academic centers involved in such research to increase participation of Hispanics and other underrepresented [...] show full description H.R.6203 - To amend the Public Health Service Act to ensure sufficient resources and increase efforts for research at the National Institutes of Health relating to Alzheimer's disease, to authorize an education and outreach program to promote public awareness and risk reduction with respect to Alzheimer's disease (with particular emphasis on education and outreach in Hispanic populations), and for other purposes.
Latest Action: 06/05/2008 - Referred to the House Committee on Energy and Commerce. Bill Text To amend the Public Health Service Act to ensure sufficient resources and increase efforts for research at the National Institutes of Health relating to Alzheimer's disease, to authorize an education and outreach program to promote public awareness and risk reduction with respect to Alzheimer's disease (with particular emphasis on education and outreach in Hispanic populations), and for other purposes. 6/5/2008--Introduced. Cure and Understanding through Research for Alzheimer's Act of 2008 or La Cura Act of 2008 - Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to ensure sufficient resources for activities relating to Alzheimer's disease and Hispanic communities, including by: (1) increasing efforts in epidemiological work in Hispanic subgroups; (2) allocating resources to the National Institute on Aging Alzheimer's disease research centers and other academic centers involved in such research to increase participation [...] show full description S.3046 - A bill to amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes.
Latest Action: 05/21/2008 - Sponsor introductory remarks on measure. (CR S4625) Bill Text A bill to amend the Federal Food, Drug, and Cosmetic Act to create a new conditional approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes. 5/21/2008--Introduced. Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met.Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act. Establishes a procedure for accelerated approval of an investigational drug, biological product, or [...] show full description H.R.6047 - To amend the Federal Food, Drug, and Cosmetic Act to mandate early access by desperately ill patients to treatment use of new drugs under clinical investigation for a serious or immediately life-threatening disease condition for whom no comparable or satisfactory drug or other therapy is available.
Latest Action: 05/15/2008 - Referred to the Subcommittee on Health. Bill Text To amend the Federal Food, Drug, and Cosmetic Act to mandate early access by desperately ill patients to treatment use of new drugs under clinical investigation for a serious or immediately life-threatening disease condition for whom no comparable or satisfactory drug or other therapy is available. 5/14/2008--Introduced. Early Access to Treatment Act - Amends the Federal Food, Drug, and Cosmetic Act to require a drug that is not approved for marketing, but that is under clinical investigation for a serious or immediately life-threatening disease condition in patients for whom no comparable or satisfactory alternative drug or other therapy is available, to be made available for treatment use by an individual patient if: (1) the drug is intended to treat such condition; (2) there is no comparable or satisfactory alternative available to treat that stage of the disease; (3) the drug is under investigation in a controlled clinical trial as an investigational new drug or all clinical [...] show full description S.2999 - A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group and individual health insurance coverage and group health plans to provide coverage for individuals participating in approved cancer clinical trials.
Latest Action: 05/08/2008 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Bill Text A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group and individual health insurance coverage and group health plans to provide coverage for individuals participating in approved cancer clinical trials. 5/8/2008--Introduced. Access to Cancer Clinical Trials Act of 2008 - Amends the Public Health Service Act, the Employee Retirement Income Security Act of 1974 (ERISA), and the Internal Revenue Code to prohibit a group health plan from: (1) denying an eligible participant or beneficiary participation in clinical trials related to the treatment of cancer that are federally funded or conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA); (2) denying (or limiting or imposing additional conditions on) the coverage of routine patient costs for items and services furnished in connection with such participation; or (3) discriminating [...] show full description S.2988 - A bill to amend the Public Health Service Act to enhance public and private research efforts to develop new tools and therapies that prevent, detect, and cure diseases.
Latest Action: 05/07/2008 - Sponsor introductory remarks on measure. (CR S3894) Bill Text A bill to amend the Public Health Service Act to enhance public and private research efforts to develop new tools and therapies that prevent, detect, and cure diseases. 5/7/2008--Introduced. Accelerating Cures Act of 2008 - Amends the Public Health Service Act to define "translational research" to mean research that transforms scientific discoveries arising from laboratory, clinical, or population studies into clinical application to reduce disease incidence, morbidity, and mortality.Establishes a Pathways to Cures Subcommittee within the Office of Portfolio Analysis and Strategic Initiatives (OPASI) of the National Institutes of Health (NIH) to help advise and direct translational research priorities.Requires the Director of NIH to establish a Federally Funded Research and Development Center (FFRDC) on clinical effectiveness research. Requires the Director of FFRDC to establish an independent Clinical Effectiveness Advisory Board.Requires the [...] show full description S.2983 - A bill to amend the Public Health Service Act to prevent and cure diabetes and to promote and improve the care of individuals with diabetes for the reduction of health disparities within racial and ethnic minority groups, including the African-American, Hispanic American, Asian American and Pacific Islander, and American Indian and Alaskan Native communities.
Latest Action: 05/06/2008 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Bill Text A bill to amend the Public Health Service Act to prevent and cure diabetes and to promote and improve the care of individuals with diabetes for the reduction of health disparities within racial and ethnic minority groups, including the African-American, Hispanic American, Asian American and Pacific Islander, and American Indian and Alaskan Native communities. 5/6/2008--Introduced. Diabetes Prevention Access and Care Act of 2008 - Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to: (1) conduct, coordinate, and support research and other activities with respect to pre-diabetes and diabetes in minority populations; and (2) conduct and support programs to treat diabetes in minority populations.Requires the Director of NIH, through the National Center on Minority Health and Health Disparities, to provide for: (1) health care professionals' mentoring; and (2) minority health professionals' participation in diabetes-focused [...] show full description S.2863 - A bill to amend the Internal Revenue Code of 1986 to provide a Federal income tax credit for certain stem cell research expenditures.
Latest Action: 04/15/2008 - Read twice and referred to the Committee on Finance. Bill Text A bill to amend the Internal Revenue Code of 1986 to provide a Federal income tax credit for certain stem cell research expenditures. 4/15/2008--Introduced.
Ethical Stem Cell Research Tax Credit Act of 2008 - Amends the Internal Revenue Code to allow a tax credit for 30% of qualified stem cell research expenses paid or incurred in a taxable year. Defines "qualified stem cell research expenses" as expenses for carrying out basic and applied research to develop techniques for the isolation, derivation, production, testing, and human clinical use of stem cells that may result in improved understanding of or treatments for diseases and other adverse health conditions. Prohibits a tax credit for any research expenses that may involve: (1) the creation of a human embryo for research purposes; (2) the destruction of or discarding of, or risk of injury to, a human embryo; or (3) the use of any stem cell for prohibited purposes. H.R.5629 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes.
Latest Action: 04/14/2008 - Referred to the Subcommittee on Courts, the Internet, and Intellectual Property. Bill Text To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 3/13/2008--Introduced. Pathway for Biosimilars Act - Amends the Public Health Service Act to allow a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product).Requires the Secretary of Health and Human Services to approve the application if: (1) the biological product is biosimilar to the reference product with respect to each condition of use for which the reference product is approved; and (2) the applicant consents to the inspection of the facility that is the subject of the application. Sets forth requirements for a determination by the Secretary that a biological product is interchangeable with a reference product.Prohibits a biological product from being evaluated against more than one reference product.Prohibits [...] show full description H.R.5605 - To amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP, and for other purposes.
Latest Action: 03/19/2008 - Referred to the Subcommittee on Health. Bill Text To amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP, and for other purposes. 3/13/2008--Introduced. Physician Payments Sunshine Act of 2008 - Amends part A of title XI of the Social Security Act to require quarterly transparency reports to the Secretary of Health and Human Services of payments to physicians or their employers, or to a covered organization in which a physician has a significant professional membership interest, by manufacturers of covered drugs, devices, or medical supplies under titles XVIII (Medicare), XIX (Medicaid), or XXI (State Children's Health Insurance Program (SCHIP)) of the Social Security Act. Amends the Internal Revenue Code to prohibit tax deductions for the advertising, promotion, or marketing by manufacturers of drugs, devices, and medical supplies on whom a [...] show full description H.R.5468 - To amend title XIX of the Social Security Act to provide Medicaid coverage of drugs prescribed for certain research study child participants.
Latest Action: 02/14/2008 - Referred to the House Committee on Energy and Commerce. Bill Text To amend title XIX of the Social Security Act to provide Medicaid coverage of drugs prescribed for certain research study child participants. 2/14/2008--Introduced.
Nino's Act - Amends title XIX (Medicaid) of the Social Security Act to provide for mandatory Medicaid coverage of drugs prescribed for certain research study child participants, regardless of Medicaid eligibility otherwise, if the state provides drug coverage. S.2629 - A bill to amend title XIX of the Social Security Act to provide Medicaid coverage of drugs prescribed for certain research study child participants.
Latest Action: 02/13/2008 - Sponsor introductory remarks on measure. (CR S975-976) Bill Text A bill to amend title XIX of the Social Security Act to provide Medicaid coverage of drugs prescribed for certain research study child participants. 2/13/2008--Introduced.
Nino's Act - Amends title XIX (Medicaid) of the Social Security Act to provide for mandatory Medicaid coverage of drugs prescribed for certain research study child participants, regardless of Medicaid eligibility otherwise, if the state provides drug coverage. S.2569 - A bill to amend the Public Health Service Act to authorize the Director of the National Cancer Institute to make grants for the discovery and validation of biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer.
Latest Action: 01/29/2008 - Sponsor introductory remarks on measure. (CR S448) Bill Text A bill to amend the Public Health Service Act to authorize the Director of the National Cancer Institute to make grants for the discovery and validation of biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer. 1/29/2008--Introduced. Ovarian Cancer Biomarker Research Act of 2008 - Amends the Public Health Service Act to require the Director of the National Cancer Institute to enter into cooperative agreements with, or make grants to, public or nonprofit entities to establish and operate centers to conduct research on biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer. Designates each center as an Ovarian Cancer Biomarker Center of Excellence.Allows federal payments under such an agreement or grant to be used for research on: (1) the development and characterization of new biomarkers and the refinement of existing biomarkers; (2) the clinical and laboratory validation [...] show full description H.R.3825 - To amend the Public Health Service Act to establish grant programs to provide for education and outreach on newborn screening and coordinated followup care once newborn screening has been conducted, to reauthorize programs under part A of title XI of such Act, and for other purposes.
Latest Action: 04/08/2008 - Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-570. Bill Text To amend the Public Health Service Act to establish grant programs to provide for education and outreach on newborn screening and coordinated followup care once newborn screening has been conducted, to reauthorize programs under part A of title XI of such Act, and for other purposes. 4/8/2008--Reported to House amended. (There is 1 other summary) Newborn Screening Saves Lives Act of 2008 - (Sec. 2) Amends the Public Health Service Act to authorize the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration (HRSA), to award grants to eligible entities to: (1) provide screening, counseling, or health care services to newborns and children having or at risk for heritable disorders; (2) provide education and training in newborn screening and congenital, genetic, and metabolic disorders to health care professionals and newborn screening laboratory personnel; (3) develop and deliver educational [...] show full description H.R.3689 - To amend the Public Health Service Act to authorize the Director of the National Cancer Institute to make grants for the discovery and validation of biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer.
Latest Action: 11/08/2007 - Referred to the Subcommittee on Health. Bill Text To amend the Public Health Service Act to authorize the Director of the National Cancer Institute to make grants for the discovery and validation of biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer. 9/27/2007--Introduced. Ovarian Cancer Biomarker Research Act of 2007 - Amends the Public Health Service Act to require the Director of the National Cancer Institute to enter into cooperative agreements with, or make grants to, public or nonprofit entities to establish and operate centers to conduct research on biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer. Designates each center as an Ovarian Cancer Biomarker Center of Excellence.Allows federal payments under such an agreement or grant to be used for research on: (1) the development and characterization of new biomarkers and the refinement of existing biomarkers; (2) the clinical and laboratory validation of such [...] show full description S.RES.332 - A resolution expressing the sense of the Senate that the Department of Defense and the Department of Veterans Affairs should increase their investment in pain management research.
Latest Action: 09/26/2007 - Referred to the Committee on Armed Services. (text of measure as introduced: CR S12156) Bill Text A resolution expressing the sense of the Senate that the Department of Defense and the Department of Veterans Affairs should increase their investment in pain management research. 9/26/2007--Introduced.
Expresses the sense of the Senate that: (1) federal funding for pain management research, treatment, and therapies, at the Department of Defense (DOD), the Department of Veterans Affairs (VA), and the National Institutes of Health (NIH) should be significantly increased; (2) Congress and the administration should redouble their efforts to ensure that a pain management program is established and implemented for military and VA treatment facilities; and (3) the DOD and VA should increase their investment in pain management clinical research. H.CON.RES.217 - To correct technical errors in the enrollment of the bill H.R. 3580.
Latest Action: 11/08/2007 - Referred to the Subcommittee on Health. Bill Text To 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. S.RES.325 - A resolution supporting efforts to increase childhood cancer awareness, treatment, and research.
Latest Action: 09/25/2007 - Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S12075-12076) Bill Text A resolution supporting efforts to increase childhood cancer awareness, treatment, and research. 9/25/2007--Passed Senate 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.) Calls for Congress to support: (1) efforts to promote awareness about the incidence, symptoms, and treatment options of cancer among children; (2) increased investment in childhood cancer research; (3) incentives to encourage medical trainees and investigators to enter the field of pediatric oncology; (4) incentives to encourage the development of drugs and biologics designed to treat pediatric cancers; (5) policies that encourage participation in clinical trials; (6) medical education curricula designed to improve pain management for cancer patients; (7) enhanced education, services, and other resources related to late effects from treatment; and (8) grassroots efforts [...] show full description H.R.3580 - To 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.
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