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 — ...
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly//File Photo Dec 9 (Reuters) - The U.S.
On Wednesday, the U.S. Food and Drug Administration (FDA) published three new draft guidances that aim to offer greater clarity to sponsors of cell and gene therapies (CGTs) on issues related to ...
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 ...
A U.S. flag, a U.S. Food and Drug Administration (FDA) logo, a syringe and a vial are seen in this illustration taken May 13, 2025. REUTERS/Dado Ruvic/Illustration (Reuters) -The U.S. Food and Drug ...
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 ...
WASHINGTON — The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to prioritize ...
The CMS created ACCESS to address barriers to care stemming from Medicare’s fee-for-service payment model. Rather than pay for specific services, Medicare will make recurring payments to healthcare ...
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 ...
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