Dr. Marty Makary, the FDA’s commissioner, said the program targets “dead time,” or about half the time between the launch of ...

The Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced on Thursday ...

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 ...

The U.S. Food and Drug Administration launched a pilot program on Monday aimed at allowing the agency to monitor clinical ...

In a landmark week for medical innovation, the FDA approved or cleared multiple breakthrough technologies, from the first gene therapy for genetic hearing loss to a wireless brain implant trial for ...

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 ...

The FDA has granted unprecedented priority review vouchers to three psychedelic drug programs targeting depression and PTSD, ...

The Food and Drug Administration Monday announced an initiative to encourage the use of RFID by drug companies. Phillips Industries’ new Cincinnati-area distribution center is now shipping aftermarket ...

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...

WASHINGTON — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Trump’s administration is causing alarm across the agency, stoking ...