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SMALL ENTITY COMPLIANCE GUIDE

Safety Reporting Requirements for INDs and BA/BE Studies Guidance for Industry and Investigators December 2012

Final

Safety Reporting Requirements for INDs and BA/BE Studies

Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco
Center for Biologics Evaluation and Research

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).


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.