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  6. Laws, Regulations, Guidances, and Enforcement Actions
  1. Office of Prescription Drug Promotion

Laws, Regulations, Guidances, and Enforcement Actions

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

Federal Food, Drug and Cosmetic Act

The following links go to the FDA web site.

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

Guidances for Industry: Advertising (search Advertising in the box above the table)

Enforcement Actions

Warning Letters and Untitled Letters