Food and Drug Administration Amendments Act of 2007
FDAAA
On Sept. 27, 2007, the President signed into law the Food and Drug Administration Amendments Act (FDAAA) of 2007. FDAAA reauthorizes some existing parts of the law and adds many new provisions to the Federal Food, Drug, and Cosmetic Act.
Introduction/News Updates/Law
Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007 - 4/21/2008
Federal Register: Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies for Purposes of the Food and Drug Administration Amendments Act of 2007 - 3/27/2008
Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS)