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.
Regulatory Affairs Professionals Society

FDA plans rules to rein in drug ads, enable proactive release of CRLs, and more

The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to ...

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 ...

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

Would you want two strangers in the room with you for hours while you're on mushrooms? The federal government just decided ...
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The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead.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 ...
The Washington Post

FDA to issue new vaccine approval guidance amid questions over coronavirus shots

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump ...
Medical Xpress

Public health groups sue FDA over policy allowing marketing of unauthorized e-cigarettes and nicotine pouches

A coalition of public health organizations, pediatricians and parents has filed a federal lawsuit challenging the Food and Drug Administration's new enforcement policy that allows e-cigarette and ...
The American Journal of Managed Care

FDA Draft Guidance Proposes CR, MRD to Accelerate MM Drug Approval

The FDA draft guidance recommends MRD and CR as endpoints for accelerated drug approval in multiple myeloma, emphasizing their role in indicating deep treatment response. MRD negativity is defined as ...

Researchers suggest ways to improve US sentencing guidelines

The U.S. Sentencing Guidelines play a pivotal role in some of the federal government's most consequential drug policy ...