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GUIDANCE DOCUMENT

Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines Draft Guidance for Industry March 2001

Draft

Not for implementation. Contains non-binding recommendations.

Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended to assist applicants and other responsible parties in fulfilling the FDA=s existing postmarketing safety reporting requirements for human marketed drug and biological products at 21 CFR 310.305, 314.80, 314.98, 600.80, and 600.81.2 Under these regulations, postmarketing safety reports must be submitted to the Agency for the following: 1. Serious and unexpected adverse experiences from all sources (domestic and foreign) 2. Spontaneously reported adverse experiences that occur domestically and that are: • Serious and expected • Nonserious and unexpected


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.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010