Drug Marketing, Advertising, and Communications
Laws, Regulations, Guidances, and Enforcement Actions
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 DDMAC's web site.
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 (PDF - 17KB) *DRAFT* (Posted 3/26/1999)
Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling (PDF - 84KB) *FINAL* (Issued 12/1997, Posted 1/12/1998)
Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (PDF - 192KB) *DRAFT* (Posted 2/4/2004)
- Example of Fictional Highlights of Prescribing Information (PDF - 106KB)
- Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule) Translated in Consumer-Friendly Language and Formatted for Use in Consumer-Directed Advertisement (PDF - 95KB)
Consumer-Directed Broadcast Advertisements (PDF - 36KB) *FINAL* (Issued 8/1999, Posted 8/6/1999)
Consumer-Directed Broadcast Advertisements Questions and Answers (PDF - 83KB) (Posted 8/6/1999)
Consumer-Directed Broadcast Advertising of Restricted Devices (PDF - 41KB) *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 (PDF - 188KB) *DRAFT* (Issued 1/26/2004, Posted 2/4/2004)
Industry-Supported Scientific and Educational Activities (PDF - 429KB) *FINAL* (Issued 12/3/1997, Posted 12/4/1997)
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 86KB) *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) (PDF - 25KB) *DRAFT* (Issued 12/1997. Posted 1/5/1998) Promoting Medical Products in a Changing Healthcare Environment:Reopening of Comment Period (PDF - 19KB)
Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling (PDF - 28KB) *DRAFT* (Issued 1/2001, Posted 1/30/2001)