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 ...

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 ...
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 ...
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 drugs.

Legal questions swirl around FDA's new expedited drug program, including who should sign off

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 agency, stoking worries ...

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.

FDA opens fast-track program to speed U.S. drug plant construction

FDA PreCheck pilot aims to speed U.S. pharma plant construction and approvals for critical medicines with earlier feedback.
PharmExec

FDA Announces New Domestic-Manufacturing-Focused Pilot Program

On February 1, FDA announced a new pilot program designed to promote the construction of domestic manufacturing sites, along ...
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 ...
BioSpace

FDA Lifts One of Two Clinical Holds on Intellia’s ATTR Gene Editing Program

After a patient safety signal and then death, the FDA in October 2025 placed holds on two of the company’s CRISPR programs ...

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

Representative Jake Auchincloss of Massachusetts took issue with the agency’s handling of the program and questioned its legal underpinnings, noting that Congress did not sign off on the plan.