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

 

The Food and Drug Administration is issuing final regulations addressing the safety reporting requirements for investigational new drug applications (INDs) found in 21 CFR part 312 and for bioavailability and bioequivalence studies found in 21 CFR part 320.

This final rule is expected to improve the quality of safety reports submitted to FDA, thereby enhancing the safety of patients in clinical trials. The final rule lays out clear, internationally harmonized definitions and standards so that critical safety information about investigational new drugs will be accurately and rapidly reported to the agency, minimizing uninformative reports and enhancing reporting of meaningful, interpretable information.

• Important Information about Enforcement of the New IND Safety Reporting Requirements (3/25/2011)
• 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) (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  • Federal Register Notice: Availability of Draft Guidance (PDF - 50KB) 
  • Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies (PDF - 41KB) 
• FDA Press Release (9/28/2010)
• Q & A: Final Rule - New Safety Reporting Requirements for Investigational New Drug Applications (INDs)