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The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab monkeys in preclinical ...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FDA Draft Guidance Places New Limits on Toxicity Tests Involving Primates

WASHINGTON - The Food and Drug Administration released a draft guidance on Tuesday significantly reducing the range of ...

FDA Official Proposes ‘Path Forward’ For Vaccines After Linking COVID Shot To Deaths Of 10 Kids

“Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via ...
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FDA issues draft guidance to reduce primate testing for certain antibodies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, ...

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 ...
Zacks Investment Research on MSN

Vaccine Stocks Fall After FDA Plans to Impose Stricter Vaccine Rules

Shares of prominent vaccine makers Moderna MRNA, BioNTech BNTX, Pfizer PFE, Novavax NVAX and Vaxcyte PCVX fell on Monday after the FDA announced plans to impose strict new vaccine requirements. What’s ...

FDA Pulls Plan to Require Asbestos Testing in Talc-Based Cosmetics

While the International Agency for Research on Cancer labels talc that may contain asbestos as “probably carcinogenic,” the ...
Becker's Hospital Review

5 FDA moves reshaping US drug policy

FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.
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 ...

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 ...