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

• Direct-to-Consumer Television Advertisements--FDAAA DTC Television Ad Pre-Dissemination Review Program *DRAFT* (Posted 3/12/2012)

• Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices *DRAFT* (Posted 12/27/2011)
• Presenting Risk Information in Prescription Drug and Medical Device Promotion *DRAFT* (Posted 5/27/2009)
• 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* (Posted 2/4/2004)
  • Labeling Example
  • Labeling Example; Consumer-Friendly Version
• Consumer-Directed Broadcast Advertisements *FINAL* (issued 8/1999, posted 8/6/1999) Questions and Answers (Posted 8/6/1999)
• Consumer-Directed Broadcast Advertising of Restricted Devices *DRAFT*(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*(Issued 1/26/2004, Posted 2/4/2004)
• Industry-Supported Scientific and Educational Activities *FINAL*  (Issued 12/3/1997, Posted 12/4/1997)
• Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling  *FINAL* (Issued 1/2012, Posted 1/31/2012)
• Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling *DRAFT* (Issued 1/24/2001, Posted 1/24/2001)

Enforcement Actions