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

Issue Date: June 11, 2014
Issued by: Center for Veterinary Medicine
Topic(s): Administrative / Procedural
Status: Draft

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

This draft guidance describes the Food and Drug Administration’s (FDA’s or Agency) current thinking on recommended practices for drug manufacturers (firms) and their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 professional 2 or health care entities 3 scientific or medical journal articles that discuss new risk information for approval prescription drugs 4, 5, 6 marketed in the United States.

Download the Guidance Document

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