OPDP Regulatory Information
Laws, Regulations, Guidances, and Compliance Letters
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- Federal Food, Drug and Cosmetic Act
- Code of Federal Regulations
- Guidances
- Compliance Letters
- Regulations
Federal Food, Drug and Cosmetic Act
- Chapter II - Definitions (Sec. 201 [321] (g)(1), (k), (m), (n), & (p))
- Chapter III - Prohibited Acts and Penalties (Secs. 301 [331], 302 [332], 303 [333], & 304 [334])
- Chapter V - Drugs and Devices (Sec. 502. [352] (a), (e), (f), & (n))
Code of Federal Regulations
The following links go to the Government Printing Office web site.
- 21 CFR 200 - General (Secs. 5, 7, & 200)
- 21 CFR 201 - Labeling Secs. 10, 100, & 200)
- 21 CFR 202 - Prescription Drug Advertising
- 21 CFR 312 - Investigational New Drug Application (Sec. 7)
- 21 CFR 314 - Applications to Market New Drug or Antibiotic (Secs. 81, 550, & 560)
Regulations
- 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* (Issued 11/20/2023. Posted 11/21/2023)
- Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner *PROPOSED* (Posted 3/29/2010)
Guidances
- Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers Guidance for Industry *REVISED DRAFT* (Issued 7/8/2024. Posted 7/9/2024)
- Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers. *REVISED DRAFT* (Issued 4/24/2024. Posted 4/25/2024)
- 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 | *FINAL* (Issued 12/26/2023. Posted 12/27/2023)
- Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers | *DRAFT* (Issued 10/23/2023. Posted 10/24/2023)
- Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements | *FINAL* (Issued 6/27/2023. Posted 6/28/2023)
- Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs | *REVISED FINAL* (Posted 4/11/2022)
- Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers | *FINAL* (Issued 6/12/2018, Updated Post 9/28/2021)
- Medical Product Communications that Are Consistent With the FDA-Required Labeling – Questions and Answers | *FINAL* (Issued 6/12/2018, Updated, Posted 9/28/2021)
- Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling | *FINAL* (Issued 12/11/2017, Posted 12/12/2017)
- Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs | *REVISED DRAFT* (Posted 8/5/2015)
- Internet/Social Media Platforms with Character Space Limitations - Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices | *DRAFT* (Posted 6/17/2014)
- Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices | FDA
- Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics | *DRAFT* (Posted 1/14/2014)
- Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices | *DRAFT* (Posted 12/27/2011)
- Presenting Risk Information in Prescription Drug and Medical Device Promotion | *DRAFT* (Posted 5/27/2009)
- Consumer-Directed Broadcast Advertisements | *FINAL* (issued 8/1999, posted 8/6/1999)
- Industry-Supported Scientific and Educational Activities | *FINAL* (Issued 12/3/1997, Posted 12/4/1997)
Compliance Letters
1997-2016 Compliance Letters are archived. To view them, please see the FDA Archive.
Resources