Biomedical Publishing on the Internet

Copyright © 2002

Thomas E. Colonna Ph.D./JD

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Module 6

Regulation of Biomedical Publishing Part 1

Both the FDA and FTC regulate the publishing of biomedical information on the Internet.  

Part 1 will include the following: 

• misbranding

• false advertising

• financial disclosure 

Reading List:

FDA Introduction to Misbranding URL: http://www.fda.gov/cdrh/devadvice/3315.html

FDA's Regulation of Internet Promotion and Advertising 

URL: http://www.devicelink.com/mddi/archive/01/07/008.html

FTC Guide to Online Marketing and Advertising 

URL: http://www.ftc.gov/bcp/conline/pubs/buspubs/ruleroad.pdf

Dot Com Disclosures 

URL: http://www.ftc.gov/bcp/conline/pubs/buspubs/dotcom/index.pdf

Combating Fraud and Deception on the Internet 

URL: http://www.ftc.gov/bcp/internet/cases-netsum.pdf

FTC Guide to Advertising Dietary Supplements 

URL: http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.pdf

FTC Guide to Media for Screening Advertisements 

URL: http://www.ftc.gov/bcp/conline/pubs/buspubs/adscreen.pdf

FTC Guides Concerning use of Endorsements and Testimonials in Advertising 

URL: http://www.ftc.gov/bcp/guides/endorse.htm

FTC Health Claims on the Internet 

URL: http://www.ftc.gov/bcp/conline/features/healthclaims.pdf

Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling  

URL: http://www.fda.gov/cder/guidance/1955dft.pdf

FDA Financial Disclosure Guidance

URL: http://www.fda.gov/cdrh/devadvice/ide/financial.shtml

Reference Material:

Guide to the FTC URL: http://www.ftc.gov/bcp/conline/pubs/general/guidetoftc.pdf

List of FTC Court Cases involving the Internet 

URL: http://www.ftc.gov/bcp/internet/cases-internet.pdf

FDA Letter Stating that Websites are Labeling 

URL: http://www.cfsan.fda.gov/~dms/labwww.html