Biomedical Publishing on the Internet
Copyright © 2002
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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
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