Biomedical Publishing on the Internet

Copyright 2002

Thomas E. Colonna Ph.D./JD

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Module 7

Regulation of Biomedical Publishing Part 2

      

FDA regulates the pre-approval and off-label promotion of biomedical products.  Part 2 covers device and pharmaceutical labeling regulations.

 

Reading List:

FDA's Device Labeling Guide "Write it Right" 

URL: http://www.fda.gov/cdrh/dsma/897.pdf

 

 

Medical Device Labeling -  Suggested Form and Content 

URL: http://www.fda.gov/cdrh/ode/labeling.pdf

 

Human Factors Principles for Medical Device Labeling 

URL: http://www.fda.gov/cdrh/dsma/227.html

 

Labeling - Regulatory Requirements for Medical Devices 

URL: http://www.fda.gov/cdrh/dsma/227.html

 

 

Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Management Companies (PBMs)  URL: http://www.fda.gov/cder/guidance/1726dft.pdf

  

Sample FDA Warning Letters Regarding Online Labeling:

Biologic Product URL: http://www.fda.gov/foi/warning_letters/g3132d.pdf

BoTox URL: http://www.fda.gov/foi/warning_letters/g1655d.pdf

Cipro URL: http://www.fda.gov/cder/warn/cyber/2001/ciproltr126.pdf

Diabetes Tea URL: http://www.fda.gov/foi/warning_letters/g3334d.pdf

Dietary Supplement URL: http://www.fda.gov/foi/warning_letters/g1936d.pdf

Feel Good Magnets URL: http://www.fda.gov/foi/warning_letters/g1549d.pdf

Ovimmune URL: http://www.fda.gov/foi/warning_letters/g1520d.pdf

Pharmaceutical URL: http://www.fda.gov/foi/warning_letters/g3008d.pdf

Physician Warning URL: http://www.fda.gov/foi/warning_letters/g1929d.pdf