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 ...

Takeaways from the AP’s report on turmoil surrounding the FDA’s new fast-track drug program

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

Exclusive-US FDA delays two drug reviews in new voucher program after safety, efficacy concerns

Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track program ...
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 ...
Yahoo

FDA names former pharmaceutical company executive to oversee US drug program

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. (AP Photo/Jose Luis Magana, File) WASHINGTON (AP) — The Food and ...
Becker's Hospital Review

FDA delays 2 drug reviews in priority voucher program

FDA delays drug reviews for two priority voucher drugs amid safety and efficacy concerns, extending timelines for Sanofi and Disc Medicine products.
JD Supra

New FDA Program Prioritizes Review of Certain ANDAs

On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic ...
STAT

FDA delays reviews for two drugs in new voucher program

Today, we discuss Trump’s lofty new health plan, see the FDA delay two drug reviews under the new voucher program, and more.
MD&M East

FDA Expands Medical Device Recall Alert Program

FDA has expanded its early alert pilot program to cover all medical devices, according to a September 29 notice. In November 2024, the FDA’s Center for Devices and Radiological Health launched the ...
Becker's Hospital Review

Lawmakers raise concerns over FDA drug voucher program

Lawmakers are pressing the FDA for answers about its Commissioner’s National Priority Voucher program, voicing concerns over potential corruption, safety risks and transparency issues. In a Nov. 20 ...
Detroit Free Press

FDA-Authorized Expanded Access Programs Utilizing Jaguar Health’s Novel Crofelemer Powder for Oral Solution to Treat Two Pediatric Intestinal Failure Patients with ...

SAN FRANCISCO, CA / ACCESS Newswire / September 30, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) is providing the company’s novel ...
WHNT

FDA names former pharmaceutical company executive to oversee US drug program

WASHINGTON (AP) — The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency’s drug program, the latest in a string of leadership changes at the agency. FDA ...