Biomedical Publishing on the Internet

Copyright 2002

Thomas E. Colonna Ph.D./JD

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Module 8

Regulation of Biomedical Publishing Part 3 


FDA regulates sponsorship of CME,  the dissemination of journal reprints, director to consumer and over-the-counter biomedical product promotion.  

Reading List:

FDA Guidance Consumer Directed Broadcast Advertising 



Consumer-Directed Broadcast Advertisements Guidance
Questions and Answers


Guidance to Industry - Industry Supported Scientific and Educational Activities  


Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices URL:


Clinical Studies Section of Labeling for Prescription Drugs and Biologics-- Content and Format  URL:


Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics 



Washington Legal Foundation White Paper on Limits to Direct to Consumer Advertising 



Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements 



Alternative to Certain Prescription Device Labeling Requirements 



Guide to Over-the-Counter (OTC) Drug Labeling