US FDA moves to curtail primate testing in drug trials

The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab monkeys in preclinical ...
The Well News on MSN

FDA Draft Guidance Places New Limits on Toxicity Tests Involving Primates

WASHINGTON - The Food and Drug Administration released a draft guidance on Tuesday significantly reducing the range of ...

Moderna stock falls after FDA vows to impose new vaccine requirements

Vinay Prasad, a top FDA official, blamed COVID shots for playing a role in the deaths of 10 children in a memo he sent to ...
Fierce Biotech

FDA issues draft guidance to reduce primate testing for certain antibodies

The FDA encourages sponsors to discuss plans to use animal testing alternatives, called new approach methodologies or NAMs, ...

FDA nixes plan to require talc-based powders to be tested for asbestos

The U.S. Food and Drug Administration canceled a proposed rule that would have required talc-based consumer products to be tested for asbestos.
Healio

FDA committees strike down monitoring requirements for schizophrenia drug

Please provide your email address to receive an email when new articles are posted on . Two FDA committees overwhelmingly voted to strike down monitoring requirements under a Risk Evaluation and ...
JD Supra

FDA summarizes LDT rule requirements in new compliance guide

FDA’s LDT final rule published in May 2024 amends FDA’s regulations to make explicit that IVDs will be regulated as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA), including when the ...
JD Supra

FDA Proposes to Overhaul Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved ...
Food Safety News

FDA proposes another delay for pre-harvest agricultural water requirements

Monday, the U.S. Food and Drug Administration (FDA) issued a supplemental notice of proposed rulemaking to extend the compliance dates for the pre-harvest agricultural water provisions as outlined in ...
STAT

Flawed FDA safety requirements are hamstringing a highly effective treatment for severe schizophrenia

For medications with serious safety concerns the Food and Drug Administration mandates a Risk Evaluation and Mitigation Strategy (REMS) “to help ensure the benefits of the medication outweigh its ...

Moderna Falls as FDA Vows to Impose New Vaccine Requirements

Vinay Prasad, a top FDA official, blamed Covid shots for playing a role in the deaths of 10 children in the memo he sent to ...