FDA fast-tracks Good Trip with approved psychedelic drugs for depression

The move comes less than a week later after President Donald Trump signed an executive order to extend research to study ...

The FDA is psyched on psychedelics. Which ones will be studied and why?

After an executive order, the FDA announced it would prioritize the study of some psychedelic drugs for therapeutic use.

FDA grants quick review for 3 psychedelic drug trials

The Food and Drug Administration on Friday granted a quick review of three experimental psychedelic drugs meant to treat ...
Regulatory Affairs Professionals Society

FDA, CMS propose new parallel review pathway for breakthrough devices

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...

The FDA just fast-tracked psychedelic drugs to treat depression. They could be here by this summer

The agency issued priority vouchers for 3 experimental new drugs using psilocybin and methylone, amid Trump’s ...
Fierce Biotech

FDA celebrates progress to end animal testing but experts warn there’s still a long way to go

Twelve months after releasing a roadmap to shift away from animal testing requirements, the FDA has declared mission ...
Becker's ASC

FDA contemplates changing approval process for software used as a medical device — 4 insights

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 ...
JD Supra

Court gives new life to the post-CRL administrative hearing process, rules that FDA can deny hearing only when evidence is ‘conclusively deficient’

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 ...