Distributing Scientific and Medical Publications on Unapproved New Uses: Recommended Practices for Pharmaceuticals and Medical Devices (Paperback) (ISBN-13: 9781797810829)

This PRINT REPLICA contains the FDA guidance for industry on Distributing Scientific and Medical Publications on Unapproved New Uses dated February 2014, and the Food and Drug Administration Modernization Act of 1997.

This is a revision of the guidance released in 2009 and is intended to clarify the ways in which a medical device manufacturer or pharmaceutical company or may use scientific and medical literature to promote its products, even if the literature doesn't conform to the FDA-approved uses for the product. This is a checklist that companies will need to consult for each instance of scientific and medical literature they wish to promote. These include medical and promotional interactions with health care professionals (HCP), Payer/Formulary Access Interactions, Publications, Grants And Continuing Medical Education (CME), Investigator Initiated Studies (IIS), and Post-Marketing Studies.
According to the Executive Director of the Coalition for Healthcare Communication, John Kamp, "Manufacturers should be able to distribute truthful information - in the form of journal articles, medical textbooks and practice guidelines."

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Author: Food and Drug Administration
ISBN-10: 1797810820
ISBN-13: 9781797810829
Publisher: Independently Published
Language: English
Published: 02/22/2019
Pages: 110
Format: Paperback
Weight: 0.60lbs
Size: 11.00h x 8.50w x 0.23d