Food and Drug Administration Safety Act of 2005

Summary

Food and Drug Administration Safety Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Drug Evaluation and Research 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 surveillance 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 general public; (5) taking corrective action if such an unreasonable risk may exist; and (6) making information about the safety and effectiveness of such drugs and biological products available to the public and health care providers in a timely manner. Requires the Drug Safety and Risk Management Drug Advisory Committee to make recommendations to the Director on postmarket studies, drugs and biological products that may present an unreasonable risk, and appropriate corrective actions. Allows the Secretary of Health and Human Services to assess civil penalties for violations of this Act. Allows the Director to withdraw or suspend approval of a drug or license for a biological product using expedited procedures under certain circumstances. Transfers to the Center the functions and duties of the Office of Drug Safety.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 18 November 2005

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• Introduced in House (PDF)

  Introduced in House · EN · 18 November 2005

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• Introduced in House

  summary · EN · 18 November 2005

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