U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Guideline for Postmarketing Reporting of Adverse Drug Experiences
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Guideline for Postmarketing Reporting of Adverse Drug Experiences March 1992

Final
Docket Number:
FDA-1985-D-0044
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The FDA published Good Guidance Practice in February 1997. This guidance was developed and issued prior to that date.


Submit Comments

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-1985-D-0044.