Silver Spring, MD, June 02, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today issued draft guidance ...
The US Food and Drug Administration (FDA) has published draft guidance for applicants for new drug applications (NDAs) and ...
FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...
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AI at the FDA: help or hindrance?
The advent of AI at the US Food and Drug Administration (FDA) is changing the complexion of the regulatory approval process for medical devices. In May, FDA commissioner Dr Martin Makary announced ...
Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...
Generic Nitenpyram Tablets become the first generic animal drug authorized under an FDA Emergency Use Authorization to treat ...
WASHINGTON (AP) — The Food and Drug Administration on Tuesday approved a generic medication for a rare brain disorder, while walking back suggestions by President Donald Trump and other administration ...
FILE - President Donald Trump listens as Dr. Marty Makary, commissioner of the Food and Drug Administration, speaks in the Roosevelt Room of the White House, Monday, Sept. 22, 2025, in Washington. (AP ...
WASHINGTON (AP) — The Food and Drug Administration on Tuesday approved a generic medication for a rare brain disorder, while walking back statements by President Donald Trump and other administration ...
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