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 ...

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 ...

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 ...
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 ...
BioSpace

FDA Policy Tracker 2026: Priority Vouchers Questioned, PRVs Return

A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns ...
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 ...
STAT

Pharmalittle: We’re reading about worries over FDA voucher program, a new U.S. Novo exec, and more

FDA leaders tried to quell concerns about a controversial new program to fast-track certain drugs at an employee town hall ...
Yahoo

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 ...

FDA launches PreCheck program to assist in building pharma plants

FDA’s new PreCheck pilot streamlines building US pharma manufacturing plants with earlier guidance and faster reviews. Read more here.
JD Supra

FDA Expands Early Alert Program to All Medical Devices

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 ...
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 ...