Laws, Regulations, Guidances, and Enforcement Actions
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The following links go to the FDA web site.
Chapter II - Definitions (Sec. 201  (g)(1), (k), (m), (n), & (p))
Chapter III - Prohibited Acts and Penalties (Secs. 301 , 302 , 303 , & 304 )
Chapter V - Drugs and Devices (Sec. 502.  (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)
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