On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission ...
The FDA is launching a National Priority Voucher program to accelerate reviews of certain new drug applications. The agency will distribute a limited number of vouchers in the program’s first year to ...
The Food and Drug Administration (FDA) has issued a statement, published electronically in the New England Journal of ...
Against a backdrop of tariff updates and a drug pricing deal from the Trump administration, the FDA charted a pair of moves this week in its push to make drug manufacturing more attractive in the U.S.
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