Development and Readiness Pilot (CDRP) program supports the acceleration of manufacturing readiness for therapies with expedited clinical development timelines Current Regenerative Medicine Advanced ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
The US Food and Drug Administration (FDA) has been using the Risk Evaluation and Mitigation Strategies (REMS) program as a way to mitigate adverse events stemming from opioid misuse and abuse, but ...
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