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OPDP Regulatory Information

Laws, Regulations, Guidances, and Enforcement Actions

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Federal Food, Drug and Cosmetic Act
Code of Federal Regulations
Guidances
Enforcement Actions 

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 99 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices

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

Note:  The FDA has recently conducted a review of its published guidances and has withdrawn the following: the March 1999 Accelerated Approval Products – Submission of Promotional Materials draft guidance, the January 2001 Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling draft guidance, and the January 2004 “Help Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms draft guidance.  See Federal Register notice.

Enforcement Actions 

 

Page Last Updated: 05/13/2015
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