H.R.788: To amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes.

To amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. 1/31/2007--Introduced. Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics 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 patient 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 [...]

show full description