Clinical Trials Arena on MSN

FDA finalises psychedelic clinical trial guidance

The FDA is holding a public hearing to talk through psychedelic drug development on 14 September.

Psychedelics guidance from the FDA set to benefit developers, including AtaiBeckley, Jefferies says

The US Food and Drug Administration's finalized guidance on psychedelic drug development signals the agency remains receptive ...
RAPS

Psychedelics: FDA offers clarifications, compromises in final clinical trial guidance

Psychedelics: FDA offers clarifications, compromises in final clinical trial guidance FDA headquarters in Silver Spring, MD. (credit: Ferdous Al-Faruque) The US Food and Drug Administration (FDA) has ...
Staten Island Advance

How is it legal to test MDMA and magic mushrooms on people? The FDA just spelled out the rules

For years, the government and the public have been curious about the use of psychedelics for medicine. Beyond typical curiosity though, there have been real developments in recent years as to how to ...
JD Supra

You Can’t Call It Cheatin’: FDA Draft Guidance Provides a Framework for Leveraging Prior Knowledge in Genome Editing Product Development

You can’t call it cheatin’, she reminds me of you,” the Gin Blossoms sang on their 1996 album Congratulations I’m Sorry. For sponsors ...
The American Journal of Managed Care

FDA Guidance to Remove One of the Largest Barriers to Biosimilar Development

The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead. This approach may lower development ...
American Lung Association

Public Health Groups, Pediatricians and Parents Sue FDA Over Policy Allowing the Marketing of Unauthorized E-Cigarettes and Nicotine Pouches

A coalition of public health organizations, pediatricians and parents today filed a federal lawsuit challenging the Food and Drug Administration’s new enforcement policy that allows e-cigarette and ...