FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...

Please provide your email address to receive an email when new articles are posted on . The FDA plans to reduce and potentially replace animal testing for developing monoclonal antibody therapies and ...

The FDA is moving away from requiring animal models for investigational new drug (IND) applications for new monoclonal antibodies and some other drug candidates. Animal testing will be "reduced, ...

(CNN) - The Food and Drug Administration said it will phase out a requirement that certain drugs and monoclonal antibodies be tested on animals. In a statement, the FDA said it’s taking this step ...

In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients.

FDA drop study requirement shifts to one study for new drugs, expanding OTC access and easing regulatory pathways for prescription switches.

This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 These include mandating the use of artificial intelligence for staffers and ...

Several stocks in the health care technology space are moving higher after the market close on Thursday after the U.S. Food and Drug Administration (FDA) announced plans to phase out animal testing ...