Biomedical Publishing on the Internet

Copyright 2002

Thomas E. Colonna Ph.D./JD

Course Map

Click here to enter the Chat room

Visit the Class Discussion Board for Q&A


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 

URL: http://www.fda.gov/cder/guidance/1804fnl.pdf

 

Consumer-Directed Broadcast Advertisements Guidance
Questions and Answers
  URL: http://www.fda.gov/cder/guidance/1804q&a.htm

 

Guidance to Industry - Industry Supported Scientific and Educational Activities  

URL: http://www.fda.gov/cder/guidance/isse.pdf

Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices URL: http://www.fda.gov/ohrms/dockets/98fr/112098a.pdf

 

Clinical Studies Section of Labeling for Prescription Drugs and Biologics-- Content and Format  URL: http://www.fda.gov/cder/guidance/1890dft.pdf

 

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

URL: http://www.fda.gov/cder/guidance/1888dft.pdf

 

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

URL: http://www.wrf.com/db30/cgi-bin/pubs/rein.pdf

 

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

URL: http://www.fda.gov/cder/guidance/2496fnl.pdf

 

Alternative to Certain Prescription Device Labeling Requirements 

URL: http://www.fda.gov/cdrh/comp/rxlabeling.pdf

 

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

URL: http://www.fda.gov/cder/otc/label/default.htm