Guidances, Federal Register Notices & Standard Operating Policy & Procedure for Advertising & Promotional Labeling

Advertising and Promotional Labeling

• Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements
• Consumer-Directed Broadcast Advertisements
  Guidance for Industry - Consumer-Directed Broadcast Advertisements
• 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
• Industry-Supported Scientific and Educational Activites
• Presenting Risk Information in Prescription Drug and Medical Device Promotion
• Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Management Companies (PBMs)
• 11/26/08 Federal Register Notice Toll-Free Number DTC TV Ads PDF
• Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final

Product Proprietary Names

• Contents of a Complete Submission for the Evaluation of Proprietary Names
• PDUFA Pilot Project: Proprietary Name Review - Concept Paper