Sources
The primary texts every rule is drawn from. All are US federal works in the public domain, fetched from the publisher and kept in full so you can check any rule against them.
Binding law
Statute and regulation. These are obligations.
21 CFR 201.56 · version 2026-09-16
Requirements on content and format of labeling for human prescription drugs
not yet drafted
21 CFR 201.57 · version 2026-09-16
Specific requirements on content and format of labeling (PI sections, boxed warning)
not yet drafted
21 CFR 202.1 · version 2026-09-16
Prescription-drug advertisements
77 rules drawn from this
21 CFR 312.7 · version 2026-09-16
Promotion of investigational drugs
5 rules drawn from this
21 CFR 314.550 · version 2026-09-16
Promotional materials — accelerated approval (drugs)
2 rules drawn from this
21 CFR 314.81 · version 2026-09-16
Other postmarketing reports (Form FDA 2253 submission)
5 rules drawn from this
21 CFR 601.12 · version 2026-09-16
Changes to an approved application (biologics; promotional labeling at (f)(4))
2 rules drawn from this
21 CFR 601.45 · version 2026-09-16
Promotional materials — accelerated approval (biologics)
2 rules drawn from this
88 FR 80958 (2023-25428) · version 2023-11-21
DTC Prescription Drug Advertisements: Major Statement in a Clear, Conspicuous, and Neutral Manner (final rule)
not yet drafted
FDA guidance
FDA's current thinking. Authoritative, but not binding — rules drawn from these are recommendations.
FDA guidance · version 2026-09-21
Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers Guidance for Industry
not yet drafted
FDA guidance · version 2026-09-21
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs
not yet drafted
FDA guidance · version 2026-09-21
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers
59 rules drawn from this
FDA guidance: Consumer-Directed Broadcast Advertisements (see document) · version 2026-09-21
Consumer-Directed Broadcast Advertisements
not yet drafted
FDA guidance · version 2026-09-21
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and Answers
not yet drafted
FDA guidance · version 2026-09-21
Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices | FDA
not yet drafted
FDA guidance · version 2026-09-21
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers
not yet drafted
FDA guidance · version 2026-09-21
Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics
not yet drafted
FDA guidance: Industry-Supported Scientific and Educational Activities (see document) · version 2026-09-21
Industry-Supported Scientific and Educational Activities
not yet drafted
FDA guidance · version 2026-09-21
Internet/Social Media Platforms with Character Space Limitations - Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
not yet drafted
FDA guidance · version 2026-09-21
Medical Product Communications that Are Consistent With the FDA-Required Labeling – Questions and Answers
19 rules drawn from this
FDA guidance · version 2026-09-21
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements
not yet drafted
FDA guidance · version 2026-09-21
Presenting Risk Information in Prescription Drug and Medical Device Promotion
30 rules drawn from this
FDA guidance · version 2026-09-21
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling
26 rules drawn from this
FDA guidance · version 2026-09-21
Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers
not yet drafted
FDA guidance · version 2026-09-21
Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs
not yet drafted
FDA guidance · version 2026-09-21
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
24 rules drawn from this
68 FR 23731 (03-10949) · version 2003-05-05
OIG Compliance Program Guidance for Pharmaceutical Manufacturers
not yet drafted