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 ...
FiercePharma

FDA finalizes guidance on promotional materials for biologics and biosimilars

A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising 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FDA Draft Guidance Proposes CR, MRD to Accelerate MM Drug Approval

The FDA draft guidance recommends MRD and CR as endpoints for accelerated drug approval in multiple myeloma, emphasizing their role in indicating deep treatment response.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 ...
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The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.

What Marty Makary Actually Got Done As FDA Commissioner

Marty Makary resigned as FDA commissioner amid controversy. But his reforms to drug review times and AI are the agency's ...
FierceBiotech

FDA outlines draft policy on MRD, complete response for accelerated approvals in multiple myeloma

After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...
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You Can’t Call It Cheatin’: FDA Draft Guidance Provides a Framework for Leveraging Prior Knowledge in Genome Editing Product Development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 ...