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GUIDANCE DOCUMENT

Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs August 2015

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs

Docket Number:
FDA-2004-D-0500
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Office of Regulatory Policy
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA) is announcing the reissuance of a revised draft guidance for industry (Revision 2) entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs.” We are reissuing the revised draft guidance to incorporate animal prescription drugs. This reissued revised draft guidance, when finalized, will assist manufacturers, packers, and distributors (firms) of human prescription drugs, including biologics, and animal prescription drugs, with meeting the brief summary requirement for prescription drug advertising and the requirement that adequate directions for use be included with promotional labeling for prescription drugs when print materials are directed toward consumers.


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:

Division of Dockets Management (HFA- 305)
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-2004-D-0500.