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.
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 ...
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 ...
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 ...
CSNews

FDA Renews Modified-Risk Claim for IQOS

According to the FDA, the authorization covers two IQOS system holders and chargers and three flavors of HeatSticks products. With this renewal, these five products may be marketed with the following ...
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 ...
BioSpaceOpinion

Opinion: Prasad’s FDA exit good for rare diseases but new CBER head must repair eroded trust

The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for ...