A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten ...
The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the ...
By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...
Orthopedics was the most active area over the second half of calendar 2025, with the FDA issuing 13 breakthrough designations to devices in the therapeutic area.
The Consolidated Appropriations Act of 2026, signed by Trump on Feb. 3, includes a provision reinstating the Mikaela Naylon ...
The US Food and Drug Administration (FDA) has granted marketing clearance to Eyonis LCS, an artificial intelligence-powered ...
At an employee town hall, FDA leaders tried to quell staff concerns about a controversial new program to fast-track certain ...
The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit requests to take part in the program. Companies are limited to one submission ...
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Legal questions swirl around FDA's new expedited drug program, including who should sign off
WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...
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