Guidances, Federal Register Notices & Standard Operating Policy & Procedure for Advertising & Promotional Labeling
Advertising and Promotional Labeling
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs(PDF - 126KB) Consumer-Directed Broadcast Advertisements (Withdrawn) Consumer-Directed Broadcast Advertising of Restricted Devices 1513 Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in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.
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 Industry-Supported Scientific and Educational Activites(PDF - 428KB) Presenting Risk Information in Prescription Drug and Medical Device Promotion(PDF - 1.2MB) Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling(PDF - 97KB) 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