article thumbnail

FDA Eliminates Animal Testing: Impact on Biotechs

The Premier Consulting Blog

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ 2] An overview of the 3Rs The FDA and other global regulatory health authorities have long embraced the 3Rs of animal research (replace, reduce, and refine).

article thumbnail

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

In effect, the revisions to the FD&C Act and the PHS Act are designed to encourage the use of alternatives to animal testing not eliminate animal testing in drug development. adequate to justify the proposed clinical testing.” The pre-existing statutory language did not require animal testing.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

New Alternative Methodologies and Their Applications in Drug Discovery and Development

biobide

Where possible, NAM s seek to avoid the use of animal testing or at least to reduce it. However, reports drawn up as recently as June 2023 still emphasize the necessity of animal testing at some point as we are still far from understanding and reproducing all the variables present in a whole organism in an in vitro or in silico model.

article thumbnail

Time for change: non-human primates in drug research

Drug Target Review

The FDA’s new roadmap In April 2025, the FDA announced a major regulatory shift with its plan to phase out the requirement for animal testing in the development of monoclonal antibodies and other drugs, when scientifically appropriate. References Animal Legal Defense Fund v. Federal ruling on USDA primate welfare petition, 2023.

article thumbnail

Article Periodic Thank You Commission unveils details on plan for phasing out animal testing for chemicals safety

Agency IQ

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

article thumbnail

Analysis Chemical Thank You ECHA issues research wish list to aid in its regulatory endeavors

Agency IQ

BY RAYAN BHARGAVA, MSC | NOV 17, 2023 4:53 PM CST Regulatory background The European Partnership for the Assessment of Risks from Chemicals (PARC) is the seven year program, lasting from 2022 to 2029, which aims to facilitate, share, and improve research on chemical risk assessment.

article thumbnail

Human neuronal cells: possibilities in drug safety testing

Drug Target Review

Our approach to seizure liability screening is especially pertinent in the context of the recent FDA modernization act which allows applicants to use methods other than animal testing to establish drug safety and effectiveness. 2023 Mar;139:105345. cited 2023 Jun 15]. Regul Toxicol Pharmacol RTP. Rockley KL.

Drugs 111