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" 




Medical Device Labeling -  Suggested Form and Content 



Human Factors Principles for Medical Device Labeling 



Labeling - Regulatory Requirements for Medical Devices 




Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Management Companies (PBMs)  URL:


Sample FDA Warning Letters Regarding Online Labeling:

Biologic Product URL:

BoTox URL:

Cipro URL:

Diabetes Tea URL:

Dietary Supplement URL:

Feel Good Magnets URL:

Ovimmune URL:

Pharmaceutical URL:

Physician Warning URL: