Drugs

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

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

Accelerated Approval Products: Submission of Promotional Materials *DRAFT* (Posted 3/26/1999)

Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling *FINAL* (Issued 12/1997, Posted 1/12/1998)

Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements *DRAFT* [HTML] or [PDF] (Posted 2/4/2004)

Consumer-Directed Broadcast Advertisements [HTML] or [PDF] *FINAL* (Issued 8/1999, Posted 8/6/1999) Questions and Answers (Posted 8/6/1999)

Consumer-Directed Broadcast Advertising of Restricted Devices *DRAFT* [HTML] or [PDF] (Issued 1/26/2004, Posted 2/4/2004)

"Help-Seeking" and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms *DRAFT* [HTML] or [PDF] (Issued 1/26/2004, Posted 2/4/2004)

Industry-Supported Scientific and Educational Activities [HTML] or [PDF] *FINAL* (Issued 12/3/1997, Posted 12/4/1997)

Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling *DRAFT* (Issued 1/1999, Posted 3/12/1999)

Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Management Companies (PBMs) *DRAFT* (Issued 12/1997. Posted 1/5/1998) Reopening of Comment Period

Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling [HTML]or [PDF] *DRAFT* (Issued 1/2001, Posted 1/30/2001)

Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements [HTML] or [PDF] *DRAFT* (Issued 4/2001, Posted 4/20/2001]