Issue Date: January 14, 2014
Issued by: Center for Veterinary Medicine
Topic(s): Antimicrobial Resistance
Status: Draft
Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.” This draft guidance responds to stakeholder requests for specific guidance on FDA’s current views on how manufacturers, packers, and distributors (firms), that may either be the applicant or acting on behalf of the applicant, of prescription human and animal drug and biological products (drugs) can fulfill regulatory requirements for postmarketing submissions of interactive promotional media for their FDA-approved products. This draft guidance clarifies FDA’s policies on what the Agency considers to be interactive promotional media.
Download the Guidance Document
