Food and Drug Administration Amendments Act of 2007

Sponsor: JOHN DINGELL (D-MI)

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 evaluation and mitigation strategies; (3) preparing and making publicly available a summary analysis of the adverse drug reaction reports received for recently approved drugs; (4) conducting screenings of the Adverse Event Reporting System database and reporting on new safety concerns; and (5) developing postmarket safety performance measures. Repeals provisions limiting postmarket safety activities to the three years after approval of a new drug. (Sec. 103) Reauthorizes prescription drug user fees beginning in FY2008.

Health Topic assigned by the Congressional Research Service.