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Consumer-Directed Broadcast Advertisements August 1999

Docket Number:
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA) is announcing a final guidance for industry entitled ``Consumer-Directed Broadcast Advertisements.'' The agency sought public comment on a draft version of this guidance, which was announced in the Federal Register of August 12, 1997. The agency considered the comments received and, where appropriate, revised the draft guidance. The final guidance describes how consumer-directed broadcast advertisements for prescription drugs for humans and animals, and human biological products, may comply with the requirement that they make adequate provision for dissemination of the approved package labeling.

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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: 97D-0302.