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GUIDANCE DOCUMENT

Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices June 2014

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2014-D-0758
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This draft guidance describes the Food and Drug Administration's (FDA's or Agency) current thinking on recommended practices for drug manufacturers (firms) and their representatives to follow if they choose tp distribute to health care professional2 or health care entities3 scientific or medical journal articles that discuss new risk information for approval prescription drugs4, 5, 6 marketed in the United States.

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-2014-D-0758.

 
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