A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten ...
President Donald Trump launched TrumpRx, a program to buy cost-effective medicine, at the White House Feb. 5. Here's what to ...
The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the ...
The US Food and Drug Administration (FDA) has granted marketing clearance to Eyonis LCS, an artificial intelligence-powered ...
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 ...
By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...
At an employee town hall, FDA leaders tried to quell staff concerns about a controversial new program to fast-track certain ...
On September 29, 2025, the U.S. Food and Drug Administration (FDA) announced the expansion of its Early Alert program to include all medical devices. This expansion builds on a pilot program that ...
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 ...
Rep. Jake Auchincloss of Massachusetts said the Commissioner’s National Priority Voucher program did not receive congressional backing. The FDA has also not yet made disclosures for eight senior ...
Big pharmaceutical companies are boosting their production capacity of branded medications with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still ...
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