House lawmaker raises new concerns over FDA’s ultra-fast drug review program

A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten ...
BioSpace

FDA Launches PreCheck Program, Intended To Bring Manufacturers Home

The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the ...
Fierce Pharma

FDA’s rare pediatric disease voucher program revived by 2026 government funding bill

The Consolidated Appropriations Act of 2026, signed by Trump on Feb. 3, includes a provision reinstating the Mikaela Naylon ...

US FDA launches program to boost domestic drug manufacturing

By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...

FDA breakthrough program starts FY2026 at steady pace

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.
Medscape

FDA Clears AI Program for Lung Cancer Screening

The US Food and Drug Administration (FDA) has granted marketing clearance to Eyonis LCS, an artificial intelligence-powered ...
STAT

FDA Commissioner Marty Makary tries to soothe staff concerns over voucher program

At an employee town hall, FDA leaders tried to quell staff concerns about a controversial new program to fast-track certain ...
Fierce Pharma

FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program

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 ...

Trump launches drug discount program. What does TrumpRx do?

President Donald Trump launched TrumpRx, a program to buy cost-effective medicine, at the White House Feb. 5. Here's what to ...
BioSpace

FDA’s Commissioner’s Priority Voucher Program ‘Shrouded in Secrecy,’ Democratic Rep Says

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 ...