FDA Announces Plan To Phase Out Animal Testing Requirement For Monoclonal Antibodies & Other Drugs

April 10 (Reuters) - FDA:

• FDA ANNOUNCES PLAN TO PHASE OUT ANIMAL TESTING REQUIREMENT FOR MONOCLONAL ANTIBODIES AND OTHER DRUGS

• FDA: ANIMAL TESTING REQUIREMENT TO BE REDUCED, REFINED OR POTENTIALLY REPLACED USING APPROACHES INCLUDING AI-BASED COMPUTATIONAL MODELS OF TOXICITY

• FDA: WILL PROMOTE USE OF LAB-GROWN HUMAN “ORGANOIDS” & ORGAN-ON-A-CHIP SYSTEMS THAT MIMIC HUMAN ORGANS TO TEST DRUG SAFETY - WEBSITE

• FDA: OVER COMING YEAR, TO LAUNCH PILOT PROGRAM ALLOWING SELECT MONOCLONAL ANTIBODY DEVELOPERS TO USE PRIMARILY NON-ANIMAL-BASED TESTING STRATEGY