U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA Organization
  4. Office of Medical Products and Tobacco
  5. Center for Drug Evaluation and Research
  6. OPDP Regulatory Information
  1. Office of Medical Products and Tobacco

OPDP Regulatory Information

OPDP Regulatory Information

Laws, Regulations, Guidances, and Enforcement Actions

Some of the links from this page take you to other government web sites. Once you leave this page, click the back button on your browser to return to OPDP's web site.

Federal Food, Drug and Cosmetic Act

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

Enforcement Actions  

1997-2014 Enforcement Actions are archived. To view them, please see the FDA Archive.

 Back to Top

ResourcesForYou

Return to the Office of Prescription Drug Promotion (OPDP)