Overview
- Released Dec. 2, the draft advises a weight-of-evidence assessment to decide whether non‑human primate toxicology is needed before first‑in‑human studies for certain monoclonal antibodies.
- The agency highlights human‑relevant alternatives such as organoids, organ‑on‑a‑chip systems, computational toxicology and real‑world data in place of routine primate studies.
- FDA officials say the approach can shave months off preclinical timelines and reduce expenses, noting macaque programs often involve about 100 animals over three months at up to roughly $50,000 per animal.
- Commissioner Marty Makary said the scheme is intended to shorten time to market for medicines and lower research and development costs.
- Contract research firm Charles River welcomed the move as advancing the 3Rs, and the step tracks with UK and EU efforts to reduce animal testing as the FDA also rolls out AI tools and review vouchers.