A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten ...
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 ...
The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the ...
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 ...
FDA leaders tried to quell concerns about a controversial new program to fast-track certain drugs at an employee town hall ...
The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit ...
FDA’s new PreCheck pilot streamlines building US pharma manufacturing plants with earlier guidance and faster reviews. Read more here.
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 agency’s program will be open to pharmaceutical facilities that align with “national priorities.” Elsewhere, a ...
FDA PreCheck pilot aims to speed U.S. pharma plant construction and approvals for critical medicines with earlier feedback.
Half of the planned 200 ALS patients have joined Medicinova’s expanded access program evaluating the experimental drug MN-166.
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