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GUIDANCE DOCUMENT

Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines Draft Guidance for Industry March 2001

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2001-D-0506
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 Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2001-D-0506.

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