Description
The Food and Drug Administration (FDA) is announcing the reissuance of a revised draft guidance for industry (Revision 2) entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs.” We are reissuing the revised draft guidance to incorporate animal prescription drugs. This reissued revised draft guidance, when finalized, will assist manufacturers, packers, and distributors (firms) of human prescription drugs, including biologics, and animal prescription drugs, with meeting the brief summary requirement for prescription drug advertising and the requirement that adequate directions for use be included with promotional labeling for prescription drugs when print materials are directed toward consumers.
Scope & Applicability
Product Classes
5Early-phase randomized, double-blind, parallel assignment clinical study
Requires analytical comparability per ICH Q5E
For animal drugs, the term serious adverse drug experience is defined in 21 CFR 514.3.
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
Human prescription drugs including biological products
Stakeholders
5layman using the drug safely
List Formats Improve Medication Instructions for Older Adults
Professional providing oversight for antimicrobial drug use; Veterinarian is to determine the actual duration that the drug will be used; Professional ordering the duration of use for antimicrobial drugs
Entity responsible for submitting NDINs
Prescribing professional who does not need to intervene for interchangeable substitution
Regulatory Context
Attributes
4Content recommendation for patient labeling
Niemela and Saariluoma study on Layout Attributes and Recall
Sheedy et al. study on Text Legibility and the Letter Superiority Effect
Refers to any reaction occurring at any dose that results in death or life-threatening outcomes.
Identified Hazards
Hazards
1Disclosing Risk Information in Consumer-Directed Print Advertisements
Related CFR Sections (9)
- 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 →
- 21CFR201.100§ 201.100 Prescription drugs for human use.
A drug subject to the requirements of section 503(b)(1) of the act shall be exempt from section 502(f)(1) if all the following conditions are met:Read full regulation →
- 21CFR201.105§ 201.105 Veterinary drugs.
A drug subject to the requirements of section 503(f)(1) of the act shall be exempt from section 502(f)(1) of the act if it is a designated medical gas (as defined in § 201.161(c)(1) ) or a medically appropriate combination of designated medical gases and is in compliance with § 201.161 , or if all tRead full regulation →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
- 21CFR514.3§ 514.3 Definitions.
The definition and interpretation of terms contained in this section apply to those terms as used throughout subchapter E.Read full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR514.8§ 514.8 Supplements and other changes to an approved application.
(a) Definitions.Read full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
Related Warning Letters (10)
- 2025-09-16
Advertising & Promotional Labeling/Drugs/Biological Products
CSL Behring
- 2025-09-16
False & Misleading Claims/Misbranded
Aytu Biopharma
- 2025-09-16
False & Misleading Claims/Misbranded
Novo Nordisk Inc.
- 2025-09-16
False & Misleading Claims/Misbranded
Eli Lilly and Company
- 2025-09-16
False & Misleading Claims/Misbranded
Alora Pharmaceuticals
- 2025-06-10
False & Misleading Claims/Misbranded
Sprout Pharmaceuticals, Inc.
- 2025-05-20
False & Misleading Claims/Misbranded
Sarfez Pharmaceuticals, Inc.
- 2025-03-11
False & Misleading Claims/Misbranded
Aurora Pharmaceutical
- 2025-03-11
False & Misleading Claims/Misbranded
Elanco Animal Health
- 2024-03-12
False & Misleading Claims/Misbranded
Boehringer Ingelheim Animal Health USA
See Also (8)
- Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (Status: Final)
- Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (Status: Final)
- Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry (Status: Final)
- Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers : Guidance for Industry (Status: Final)
- Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final (Status: Final)
- Contents of a Complete Submission for the Evaluation of Proprietary Names (Status: Final)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Status: Draft)
- Expedited Programs for Serious Conditions | Drugs and Biologics (Status: Final)