Advertising and Promotional Labeling

• Accelerated Approval Products —Submission of Promotional Materials (PDF - 17KB)
• Disclosing Risk Information in Consumer-Directed Print Advertisements: Brief Summary (PDF - 363KB)
• Consumer-Directed Broadcast Advertisements
• (Withdrawn) Consumer-Directed Broadcast Advertising of Restricted Devices 1513
• Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner.
  Proposed Rule
• Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices
• “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms (PDF - 233KB)
• Industry-Supported Scientific and Educational Activites (PDF - 428KB)
• Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 377KB)
• Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 153KB)
• Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Management Companies (PBMs) (PDF - 25KB)
• 11/26/08 Federal Register Notice Toll-Free Number DTC TV Ads PDF 11/26/08 Federal Register Notice Toll-Free Number DTC TV Ads PDF

Product Proprietary Names

• SOPP 8001.4: Review of CBER Regulated Product Proprietary Names
• Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
• PDUFA Pilot Project: Proprietary Name Review - Concept Paper (PDF - 186KB)
• Federal Register Notice, 10/1/09, Pilot Program To Evaluate Proposed Proprietary Name Submissions; Procedures To Register for Participation and Submit Data

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