OPDP Regulatory Information
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- Chapter II - Definitions (Sec. 201  (g)(1), (k), (m), (n), & (p))
- Chapter III - Prohibited Acts and Penalties (Secs. 301 , 302 , 303 , & 304 )
- Chapter V - Drugs and Devices (Sec. 502.  (a), (e), (f), & (n))
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)
- 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)
- 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)
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)
- Direct-to-Consumer Television Advertisements--FDAAA DTC Television Ad Pre-Dissemination Review Program *DRAFT* (Posted 3/12/2012)
- 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) Questions and Answers (Posted 8/6/1999)
- Industry-Supported Scientific and Educational Activities *FINAL* (Issued 12/3/1997, Posted 12/4/1997)
1997-2014 Enforcement Actions are archived. To view them, please see the FDA Archive.