Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug Administration Amendments Act of 2007 Direct-to-Consumer Television Ad Pre-Dissemination Review Program; Availability

Resumen

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Direct-to- Consumer Television Advertisements--FDAAA DTC Television Ad Pre- Dissemination Review Program." This draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements (TV ads) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). (The term "pre- dissemination review" is used throughout the guidance to refer to review under the FD&C Act, which is entitled "Prereview of Television Advertisements.") The draft guidance describes which TV ads FDA intends to make subject to this provision, explains how FDA will notify sponsors that an ad is subject to review under this provision, and describes the general and center-specific procedures sponsors should follow to submit their TV ads to FDA for pre-dissemination review in compliance with the FD&C Act. These proposed TV ads will be subject to a 45-calendar day review clock by FDA.