U.S. Congress - H.R.2273 Food and Drug Administration Improvement Act of 2007
H.R.2273 - Food and Drug Administration Improvement Act of 2007
To 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. view all titles (2)
All Bill Titles
- Official: To 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. as introduced.
- Short: Food and Drug Administration Improvement Act of 2007 as introduced.
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Official Summary
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 TreasuryOfficial Summary
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 from whom such fees are collected and terminates any existing agreements. Requires the Secretary to:
(1) establish the Center for Postmarket Drug Safety and Effectiveness within the Food and Drug Administration (FDA) to regulate approved drugs; and
(2) transfer to the Center all responsibilities for such regulation from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Allows the Secretary to require manufacturers of approved drugs to conduct studies of an identified significant safety issue with the drug. Deems a drug to be misbranded if it does not meet the Secretary's requirements, including requirements for labeling and conducting postmarket studies. Requires the Secretary to follow the interpretation that the FDA used in 1999 that the FFDCA and Public Health Service Act establish minimal standards but do not preclude additional state requirements. Requires the Secretary to cease intervening in product liability civil actions to argue another interpretation. Sets forth procedures for advisory committee meetings to ensure that the committee is fairly balanced. Prohibits any exemptions from being granted to advisory committee members from rules prohibiting members from having a personal financial interest in the outcome. Requires doctors to inform patients and obtain consent to prescribe an approved drug for a purpose that has not been approved by the FDA.
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Recent Blog Coverage
H.R.2273: Nurse Staffing Standards for Patient Safety and Quality ...
A companion bill, H.R. 2273, has been introduced in the House.The measures would increase the number of nurses needed by hospitals and also raise nurses' salaries. Specifically, if the bills are passed:- the operating costs of an ... Source: Bangor Dai
board of trustees of the university of alabama et al. v. garrett ...
americans with disabilities act of 1989: hearings on hr 2273 before the house committee on the judiciary and the subcommittee on civil and constitutional rights, 101st cong., 1st sess. (1989). americans with disabilities act: hearing on ...
Updates
HR 2273: The bill on Biofuels Research and Development Enhancement was reported (amended) by the Committee on Science and Technology and placed on the Union Calednar, No. 189. HR 3093: Blog Article Status Report ...
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