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  1. Center for Drug Evaluation and Research | CDER

OPDP Regulatory Information

Laws, Regulations, Guidances, and Compliance 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)

Regulations

    Guidances

    Compliance Actions  

    1997-2016 Compliance Actions are archived. To view them, please see the FDA Archive.

    Resources

    Return to the Office of Prescription Drug Promotion (OPDP)

     
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