Biomedical Publishing on the Internet
Copyright © 2002
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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
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