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GUIDANCE DOCUMENT

Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics January 2014

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2013-N-1430
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal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 This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers, packers, and distributors (firms), that may either be the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 This draft guidance clarifies FDA's policies on what the Agency considers to be interactive promotional media.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-N-1430.