Medical device manufacturers and distributors have come under increasing scrutiny from state licensing agencies and operating without a required license may lead to severe consequences. These can include financial penalties;...more
The regulatory environment for prescription medical device manufacturers and distributors has become increasingly stringent as state-based agencies work to ensure public health and safety. Operating without a required license...more
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
State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own licensing requirements, which can...more
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
1/14/2025
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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