火曜日, 2月 01, 0023

20100928 FDA 21CFR part312 IND Safety Reporting Requirements

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Federal Register Notice: Availability of Draft Guidance (PDF - 50KB)3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)

20100928 FDA Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies