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; and (3) conducting screenings of the Adverse Event Reporting System database and reporting on new safety concerns. (Sec. 103) Reauthorizes prescription drug user fees beginning in FY2008. Requires the Secretary of Health and Human Services (the Secretary) to provide a partial refund of an applicant's user fees if the application is withdrawn without a waiver before filing.

Health Topic assigned by the Congressional Research Service. CRS gives each bill one topic, based on the bill as introduced. This one carries 115 subject terms, so it spans well beyond that single label.