HR 4429 · 109th Congress · Health
Food and Drug Administration Safety Act of 2005
Bill Progress
✓
Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Referred to the Subcommittee on Health.(2005-12-02)
Plain Language Summary
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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 Direc…
Summarized by Claude AI · Non-partisan · For informational purposes only
Cosponsors (3)
2 Democrats1 Republican