Issue Date: December 20, 2012
Issued by: Center for Drug Evaluation and Research
Topic(s): Generic Drugs, Good Clinical Practice (GCP), Safety – Issues, Errors, and Problems
Status: Final
Safety Reporting Requirements for INDs and BA/BE Studies: Guidance for Industry and Investigators
This guidance is intended to help small businesses understand and comply with FDA’s safety reporting regulations for human drug and biological products that are being investigated under an investigational new drug application (IND) and for drugs that are the subjects of bioavailability (BA) and bioequivalence (BE) studies that are exempt from the IND requirements. The FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).
Download the Guidance Document
