Description
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal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 This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers, packers, and distributors (firms), that may either be the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 This draft guidance clarifies FDA's policies on what the Agency considers to be interactive promotional media.
Scope & Applicability
Product Classes
6Products subject to clinical investigation guidance.
Products for which batch/lot information is particularly important
Subject to postmarketing submission requirements for promotional media.
Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
Drugs subject to section 512 of the FD&C Act
Includes biological products
Stakeholders
4Paid speaker acting on behalf of the firm.
Agent acting on behalf of the firm.
Entity submitting development data and knowledge; Entity performing the work process for change
Entity responsible for submitting NDINs
Related CFR Sections (5)
- 21CFR202.1§ 202.1 Prescription-drug advertisements.
Prescription drug as used in this section means any drug defined in section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act or § 201.105 of this chapter , applicable to drugs intended for use by humans and to veterinary drugs, respectively.Read full regulation →
- 21CFR1.3§ 1.3 Definitions.
(a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce.Read full regulation →
- 21CFR514.80§ 514.80 Records and reports concerning experience with approved new animal drugs.
The following table outlines the purpose for each paragraph of this section:Read full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →
Related Warning Letters (1)
- 2025-09-16
False & Misleading Claims/Misbranded
Aytu Biopharma
See Also (8)
- Presenting Risk Information in Prescription Drug and Medical Device Promotion (Status: Draft)
- Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Guidance for Industry and Review Staff (Status: Final)
- Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers (Status: Draft)
- Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry (Status: Final)
- Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Status: Final)
- Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry (Status: Final)
- Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (Status: Final)
- Regulatory Considerations for Prescription Drug Use-Related Software (Status: Draft)