FDA commissioner Marty Makary told NBC News that the first psychedelic drug could be approved in the U.S. as soon as this summer.

The FDA announced on April 24, 2026, that it has granted a new class of accelerated review vouchers to three psychedelic drug programs, a move that could compress the agency’s standard 10- to 12-month review window to roughly one to two months once a company submits its final application.

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel review program to expedite certain Class II and Class III breakthrough medical devices to market for Medicare patients called the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway.

The FDA’s new practice of releasing redacted complete response letters (CRLs) in the name of “radical transparency” is ruffling some feathers in the drug industry, as illustrated through a new peti | The citizen petition takes issue with the FDA's new practice of publicly releasing batches of complete response letters in response to unapproved drug applications.

On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence.” The Court ruled that FDA had erred in dismissing ...

Some psychedelic drugs, once considered fringe, are now getting a step closer to possibly being approved for use as mental health treatments in the United States.

The FDA is contemplating changing its medical device for software approval process, JD Supra reports. Here’s what you should know. 1. Software as a medical device applies to all software used to regulate medical devices. Treatment-planning software that ...

The FDA issued a complete response letter regarding AbbVie’s biologics license application for trenibotulinumtoxinE, a fast-acting botulinum toxin, requesting more information about its manufacturing processes,