FDA Releases Draft Guidance on Promotional Labeling and Advertising

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The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.

FDA has released draft guidance on promotional labeling and advertising materials, specifically for submissions made to the Center for Drug Evaluation and Research’s Office of Prescription Drug Promotion (OPDP) and the Center for Biologics Evaluation and Research’s Advertising and Promotional Labeling Branch (APLB).  The draft guidance provides information on aspects of electronic submission of promotional materials in module 1 of the electronic Common Technical Document using version 3.3 or higher of the us-regional-backbone file.

Included in the guidance document are details on OPDP and APLB’s procedures for submitting promotional materials to fulfill postmarketing reporting requirements. The guidance also includes information on presubmission of promotional materials for accelerated approval products; promotional materials submitted pursuant to Section 503C of the FD&C Act; promotional materials submitted voluntarily for advisory comments; resubmissions; and more.  The guidance addresses both paper and electronic submissions.


Source: FDA.gov