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Prescription Medical Device Manufacturers, Distributors, and the NABP: The Role in State Licensing

The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers and distributors. Although the NABP does not directly regulate the...more

FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more

FDA proposal classifying wound dressings/washes with antimicrobials may require PMAs, new 510(k)s

Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing antimicrobials, which would categorize...more

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