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

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...

FDA’s 2025 Biosimilar Draft Guidance: Strategic Considerations for Clients and Counsel

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...
BioSpace

CDMOs Pin Hopes for Accelerating Uptake at New US Sites on FDA’s PreCheck Program

The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...

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

Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration ...
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 ...
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 ...
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 ...
MM&M

FDA’s new national priority voucher program wants to speed up drug approvals while lowering drug costs

FDA commissioner Dr. Marty Makary is beginning to make moves toward his promise of speeding up drug approval pathways at the agency. But he’s aiming to do things a bit differently than in the past — ...
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 ...
Managed Healthcare Executive

Patients may not see savings from new Medicare drug programs

He explained that there is no provision in GLOBE or GUARD that changes what plans, hospitals or pharmacists pay for prescription drugs, and there is no mechanism for shifting the any savings to ...