FDA panel considers loosening regulations for some peptides

The FDA panel will review seven peptides and decide if they should be added to a list of substances that can be safely ...
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.
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 ...

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

FDA drafts guidance on best practices for responding to inspection observations

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.

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FDA Draft Guidance Proposes CR, MRD to Accelerate MM Drug Approval

The FDA draft guidance recommends MRD and CR as endpoints for accelerated drug approval in multiple myeloma, emphasizing their role in indicating deep treatment response.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 ...
The American Journal of Managed Care

FAQs: FDA Lawsuit Challenges E-Cigarette Enforcement Policy, PMTA Guidance

Multiple health organizations and individual plaintiffs challenge FDA “enforcement discretion” for unauthorized ENDS and nicotine pouches, asserting it effectively permits continued marketing during ...
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You Can’t Call It Cheatin’: FDA Draft Guidance Provides a Framework for Leveraging Prior Knowledge in Genome Editing Product Development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 National Law Review

New FDA Guidance Could Speed Biosimilar Approvals and Cut Costs

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...