FDA grants quick review for 3 psychedelic drug trials

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

FDA moves to fast-track psychedelic drug reviews after Trump directive

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.
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 accomplished for its first-year goals. | The FDA says it has hit the one-year goals of its roadmap for ending animal testing.
RAPS

New FDA Document Clarifies IND Process for Drugs, Biologics and Biosimilars

A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new drug (IND) applications. INDs are used by pharmaceutical ...

FDA moves to fast-track review of psilocybin and methylone for mental health

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.
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.” The Court ruled that FDA had erred in dismissing ...
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 regulate medical devices. Treatment-planning software that ...

FDA and CMS outline new Medicare coverage pathway for medical device access

The agencies’ initiative is intended to speed up the processes involved in medical devices’ securing Medicare coverage once approved by the FDA.
Fierce Pharma

FDA citizen petition calls on agency to tighten up CRL disclosure practices

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.