This draft guidance pertains to submissions of promotional materials for human prescription drugs (drugs) to the Food and Drug Administration (FDA or the Agency) made by manufacturers, packers, and distributors (firms), whether the applicant or an entity acting on behalf of the applicant. Specifically, this draft guidance pertains to submissions made to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER), and explains certain aspects of electronic submission of promotional materials in module 1 of the electronic Common Technical Document (eCTD) using version 3.3 or higher of the us-regional-backbone file. 

 

For the purpose of this draft guidance, the terms promotional materials and promotional pieces collectively refer to advertising (ads) and promotional labeling materials, regardless of the format, manner, or medium by which they are presented. Promotional materials may include, but are not limited to, television ads, brochures, booklets, detailing pieces, Internet websites, print ads, exhibits, sound recordings, and radio ads. 

 

 

Posted on the FDA website on 22 April 2015