OPDP Regulatory Information
Laws, Regulations, Guidances, and Compliance Actions
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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)
Guidances
- Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products--Questions and Answers "DRAFT" (Issued 2/3/2020. Posted 2/4/2020)
- Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs *FINAL* (Issued 6/21/2019, Posted 6/24/2019)
- Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements Guidance for Industry *DRAFT* (Issued 10/16/2018, Posted 10/17/2018)
- Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers *FINAL* (Issued 6/12/2018, Posted 6/12/2018)
- Medical Product Communications that Are Consistent With the FDA-Required Labeling – Questions and Answers *FINAL* (Issued 6/12/2018, Posted 6/12/2018)
- 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 (PDF - 176KB) *DRAFT* (Posted 6/17/2014)
- Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (PDF - 136KB) *DRAFT* (Posted 6/17/2014)
- Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products - Recommended Practices *DRAFT* (Posted 6/6/2014)
- Distributing Scientific and Medical Publications on Unapproved New Uses - Recommended Practices *REVISED DRAFT* (Posted 2/28/2014)
- 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 Actions
- Warning Letters
- Untitled Letters 2021
- Untitled Letters 2020
- Untitled Letters 2019
- Untitled Letters 2018
- Untitled Letters 2017
1997-2016 Compliance Actions are archived. To view them, please see the FDA Archive.
Resources For You
Return to the Office of Prescription Drug Promotion (OPDP)