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Federal Food, Drug and Cosmetic Act
Code of Federal Regulations
Guidances
Enforcement Actions
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))
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)
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]
Warning Letters and Untitled Letters
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
