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Also tagged in: Administrative procedure, Administrative remedies, Congressional reporting requirements, Consumer education, Consumer protection, Consumers, Defective products, Department of Health and Human Services, Drugs, Electronics, Executive departments, Food, Food and Drug Administration (FDA), Food safety, Governmental investigations, Law, Medical care, Medical instruments and apparatus, Medical supplies, Medicine, Product safety, Technology
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, Administrative fees, Administrative procedure, Administrative remedies, Animals, Antibiotics, Authorization, Budgets, Business, Cancer, Child health, Children, Civil liberties, Clinical trials, Communications, Computer security measures, Conflict of interests, Congressional investigations, Congressional reporting requirements, Consumer education, Consumers, Data banks, Deceptive advertising, Department of Health and Human Services, Directories, Drug advertising, Drug approvals, Drug industry, Drug interactions, Drugs, Electronic data interchange, Electronic government information, Executive departments, Executive reorganization, Federal advisory bodies, Federal aid to research, Food, Food and Drug Administration (FDA), Food safety, Foreign corporations, Foundations, Fund raising, Gifts, Government information, Government paperwork, Government publicity, Health information systems, Health policy, Identification devices, Imaging systems in medicine, Imports, Intellectual property, Inventions, Inventors, Labeling, Law, Licenses, Medical care, Medical ethics, Medical innovations, Medical instruments and apparatus, Medical records, Medical research, Medical supplies, Medicine, National Institutes of Health (NIH), Nonprofit organizations, Nosocomial infections, Nuclear medicine, Orphan drugs, Patents, Pediatrics, Performance measurement, Pharmaceutical research, Physicians, Product counterfeiting, Product development, Product safety, Profit, Public-private partnerships, Research and development, Research grants, Right of privacy, Risk, Science policy, Small business, Social services, Technology, Telecommunication, Telephone, Television advertising, Trade, User charges, Veterinary medicine
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: 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, Clinical trials, Communicable diseases, Communication in medicine, Communications, Conflict of interests, Congress, Congressional investigations, Congressional oversight, Congressional reporting requirements, Consumer education, Consumers, Counterfeiting, Criminal justice, Data banks, Defective products, Department of Health and Human Services, Drug abuse, Drug adulteration, Drug approvals, Drug industry, Drug interactions, Drug law enforcement, Drug therapy, Drug utilization, Drugs, Education, Electronic data interchange, Elementary and secondary education, Environmental protection, Executive departments, Eye diseases, Families, Federal advisory bodies, Federal aid to education, Federal aid to research, Federal reserve system, Fines (Penalties), Food, Food additives, Food and Drug Administration (FDA), Food industry, Food preservation, Food safety, Food supply, Foodborne diseases, Foundations, Fraud, Generic drugs, Genetic counseling, Genetic engineering, Genetics, Government information, Government paperwork, Government publicity, Hazardous substances, Health information systems, Health surveys, Health warnings, Higher education, Imaging systems in medicine, Import restrictions, Intellectual property, Internet, Labeling, Law, Marijuana, Meat, Medical care, Medical education, Medical instruments and apparatus, Medical laboratories, Medical records, Medical statistics, Medical supplies, Medicinal plants, Medicine, Orphan drugs, Packaging, Parent and child, Parental consent, Patent infringement, Pediatrics, Pesticides, Pets, Pharmaceutical research, Pharmacists, Physical examinations, Politics and government, Preschool education, Prescription pricing, Prices, Produce trade, Product development, Product safety, Protection of animals, Public meetings, Research and development, Research grants, Restrictive trade practices, Risk, Salmonella, Scholarships, Science policy, Seafood, Shellfish, Skin cancer, Skin diseases, Small business, Social services, Strategic planning, Student loan funds, Technology, Telecommunication, Trade, Turtles, User charges, Web sites
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: 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, Communicable diseases, Communication in medicine, Communication in science, Communications, Conflict of interests, Congress, Congressional investigations, Congressional reporting requirements, Consumer education, Consumers, Criminal justice, Criminal justice information, Data banks, Deceptive advertising, Department of Health and Human Services, Direct mail advertising, Directories, Drug advertising, Drug approvals, Drug industry, Drug resistance in microorganisms, Drugs, Electronic data interchange, Electronic government information, Emergency communication systems, Emergency management, Employee training, Environmental assessment, Environmental protection, Executive departments, Executive reorganization, Eye diseases, Federal advisory bodies, Federal employees, Federal officials, Federal preemption, Financial disclosure, Fines (Penalties), Food and Drug Administration (FDA), Food labeling, Food safety, Foundations, Fund raising, Generic drugs, Genetic engineering, Genetic research, Gifts, Government employees, Government information, Government paperwork, Government publicity, Grants-in-aid, Hazardous substances, Health information systems, Health policy, Health surveys, Humanities, Identification devices, Imports, Intellectual property, Internet, Inventors, Job training, Labeling, Law, Local laws, Medical associations, Medical care, Medical ethics, Medical instruments and apparatus, Medical supplies, Medicine, Nonprofit organizations, Nosocomial infections, Orphan drugs, Patents, Pediatrics, Peer review organizations (Medicine), Performance measurement, Pesticides, Pharmaceutical research, Physicians, Product counterfeiting, Product development, Product safety, Public contracts, Public meetings, Public-private partnerships, Radioisotopes in medicine, Research and development, Research grants, Right of privacy, Risk, Science policy, Scientists in government, Seafood, Skin cancer, Small business, Social services, Standards, State and local government, State laws, Technology, Telecommunication, Television advertising, Terrorism, Trade, Trade agreements, Trade negotiations, User charges, Veterinary medicine, Warning labels
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
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Latest Legislation - View All
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, Communicable diseases, Communication in medicine, Communication in science, Communications, Conflict of interests, Congress, Congressional investigations, Congressional reporting requirements, Consumer education, Consumers, Criminal justice, Criminal justice information, Data banks, Deceptive advertising, Department of Health and Human Services, Direct mail advertising, Directories, Drug advertising, Drug approvals, Drug industry, Drug resistance in microorganisms, Drugs, Electronic data interchange, Electronic government information, Emergency communication systems, Emergency management, Employee training, Environmental assessment, Environmental protection, Executive departments, Executive reorganization, Eye diseases, Federal advisory bodies, Federal employees, Federal officials, Federal preemption, Financial disclosure, Fines (Penalties), Food and Drug Administration (FDA), Food labeling, Food safety, Foundations, Fund raising, Generic drugs, Genetic engineering, Genetic research, Gifts, Government employees, Government information, Government paperwork, Government publicity, Grants-in-aid, Hazardous substances, Health information systems, Health policy, Health surveys, Humanities, Identification devices, Imports, Intellectual property, Internet, Inventors, Job training, Labeling, Law, Local laws, Medical associations, Medical care, Medical ethics, Medical instruments and apparatus, Medical supplies, Medicine, Nonprofit organizations, Nosocomial infections, Orphan drugs, Patents, Pediatrics, Peer review organizations (Medicine), Performance measurement, Pesticides, Pharmaceutical research, Physicians, Product counterfeiting, Product development, Product safety, Public contracts, Public meetings, Public-private partnerships, Radioisotopes in medicine, Research and development, Research grants, Right of privacy, Risk, Science policy, Scientists in government, Seafood, Skin cancer, Small business, Social services, Standards, State and local government, State laws, Technology, Telecommunication, Television advertising, Terrorism, Trade, Trade agreements, Trade negotiations, User charges, Veterinary medicine, Warning labels
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: 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, Conflict of interests, Congressional investigations, Congressional reporting requirements, Consumer education, Consumers, Data banks, Deceptive advertising, Department of Health and Human Services, Directories, Drug advertising, Drug approvals, Drug industry, Drug interactions, Drugs, Electronic data interchange, Electronic government information, Executive departments, Executive reorganization, Federal advisory bodies, Federal aid to research, Food, Food and Drug Administration (FDA), Food safety, Foreign corporations, Foundations, Fund raising, Gifts, Government information, Government paperwork, Government publicity, Health information systems, Health policy, Identification devices, Imaging systems in medicine, Imports, Intellectual property, Inventions, Inventors, Labeling, Law, Licenses, Medical care, Medical ethics, Medical innovations, Medical instruments and apparatus, Medical records, Medical research, Medical supplies, Medicine, National Institutes of Health (NIH), Nonprofit organizations, Nosocomial infections, Nuclear medicine, Orphan drugs, Patents, Pediatrics, Performance measurement, Pharmaceutical research, Physicians, Product counterfeiting, Product development, Product safety, Profit, Public-private partnerships, Research and development, Research grants, Right of privacy, Risk, Science policy, Small business, Social services, Technology, Telecommunication, Telephone, Television advertising, Trade, User charges, Veterinary medicine
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: Administrative procedure, Administrative remedies, Congressional reporting requirements, Consumer education, Consumer protection, Consumers, Defective products, Department of Health and Human Services, Drugs, Electronics, Executive departments, Food, Food and Drug Administration (FDA), Food safety, Governmental investigations, Law, Medical care, Medical instruments and apparatus, Medical supplies, Medicine, Product safety, Technology
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: 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, Clinical trials, Communicable diseases, Communication in medicine, Communications, Conflict of interests, Congress, Congressional investigations, Congressional oversight, Congressional reporting requirements, Consumer education, Consumers, Counterfeiting, Criminal justice, Data banks, Defective products, Department of Health and Human Services, Drug abuse, Drug adulteration, Drug approvals, Drug industry, Drug interactions, Drug law enforcement, Drug therapy, Drug utilization, Drugs, Education, Electronic data interchange, Elementary and secondary education, Environmental protection, Executive departments, Eye diseases, Families, Federal advisory bodies, Federal aid to education, Federal aid to research, Federal reserve system, Fines (Penalties), Food, Food additives, Food and Drug Administration (FDA), Food industry, Food preservation, Food safety, Food supply, Foodborne diseases, Foundations, Fraud, Generic drugs, Genetic counseling, Genetic engineering, Genetics, Government information, Government paperwork, Government publicity, Hazardous substances, Health information systems, Health surveys, Health warnings, Higher education, Imaging systems in medicine, Import restrictions, Intellectual property, Internet, Labeling, Law, Marijuana, Meat, Medical care, Medical education, Medical instruments and apparatus, Medical laboratories, Medical records, Medical statistics, Medical supplies, Medicinal plants, Medicine, Orphan drugs, Packaging, Parent and child, Parental consent, Patent infringement, Pediatrics, Pesticides, Pets, Pharmaceutical research, Pharmacists, Physical examinations, Politics and government, Preschool education, Prescription pricing, Prices, Produce trade, Product development, Product safety, Protection of animals, Public meetings, Research and development, Research grants, Restrictive trade practices, Risk, Salmonella, Scholarships, Science policy, Seafood, Shellfish, Skin cancer, Skin diseases, Small business, Social services, Strategic planning, Student loan funds, Technology, Telecommunication, Trade, Turtles, User charges, Web sites
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
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