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 ...
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 ...
Medical Marketing & Media

FDA takes first step toward ‘de facto’ ad ban: What to know

The FDA has proposed a new rule that would seek to eliminate the adequate provision guidance in pharma DTC ads.

FDA Proposes Rule to Modernize Drug Manufacturing Registration

The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined ...
Regulatory Affairs Professionals Society

FDA proposes rule to ease registration for distributed manufacturers, require foreign API sites to register

The US Food and Drug Administration (FDA) on Friday outlined a set of proposed reforms to advance modern manufacturing ...
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 ...

From caffeine to 'healthy' labeling, FDA sets year-end agenda for US food supply

The U.S. Food and Drug Administration (FDA) has announced the food supply issues it seeks to tackle by year's end.
STAT

5 burning questions on the FDA’s new Covid-19 vaccine framework

Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health.
SGB Online

EXEC: Whoop Gets a Win for BPI Feature as FDA Officially Drops its Warning Letter

The U.S. Food and Drug Administration (FDA) has officially dropped its warning letter and enforcement complaint against Whoop ...
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 ...
The Manila Times

Memphis Surgeon Seeks to Overturn Conviction, Citing FDA Guidance on Medical Devices with National Experts Aghast at Overzealous Persecution Despite FDA Safe Harbor

Sworn Declarations from Former FDA Counsel and Renowned Device Regulation Expert Expose Clear Regulatory Carve-Outs for Outpatient Clinics; Emergency Motion Seeks to Strike Verdict Before July 7 Sente ...
The American Journal of Managed Care

FDA Approves Atacicept for IgA Nephropathy

ORIGIN 3 randomized 431 biopsy‑confirmed IgAN patients 1:1; atacicept 150 mg weekly SC produced the largest placebo‑adjusted UPCR reduction reported at week 36. Accelerated approval hinged on ...