Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans (PDF - 163KB)1 (Final Rule)
Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies (Draft) (PDF - 688KB)
Federal Register Notice: Availability of Draft Guidance (PDF - 50KB)3
FDA Press Release4 (9/28/2010)
Q & A: Final Rule - New Safety Reporting Requirements for Investigational New Drug Applications (INDs)
