New FDA Draft Guidance on DTC Television Advertisements
The US Food and Drug Administration (FDA) released new draft guidance 12 March on how FDA intends to review TV advertisements before they are disseminated to the public.
Guidance for Industry - Direct-to-Consumer Television Advertisements - FDAAA DTC Television Ad Pre-Dissemination Review Program "describes the types of TV ads that FDA intends to be subject to this provision, explains how FDA will notify sponsors that an ad is subject to the requirement of review under section 503B, 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 section 503B of the FD&C Act."
The guidance is the result of the Food and Drug Administration Amendments Act (FDAAA) of 2007, in which FDA is given authority to require all television advertisements be submitted to the agency for review at least 45 days in advance of public dissemination of the advertisement.
FDA may then request changes to ensure consumer understanding, safe prescribing, adherence to the approved label, the clarity of all statements and the inclusion all relevant information.
Read more: