The Food and Drug Administration (FDA) on Oct. 16 announced the first batch of drugs that will receive expedited reviews under the Commissioner’s National Priority Voucher (CNPV) pilot program.
“Voucher recipients will receive a decision within 1–2 months following filing of a complete application for a drug or biologic,” the FDA said, far outpacing the previous timelines.
Currently, the FDA’s accelerated approval track, reserved for therapies targeting life-threatening illnesses, usually takes about six months, and routine reviews last up to roughly 10 to 12 months.
The new CNPV process “accelerates the standard 10–12 month timeline by convening a multidisciplinary team of physicians and scientists for a team-based review, interacting frequently with the sponsor to clarify questions, and completing review of the application concurrently,” the FDA said in a statement….
FDA Unveils 9 Drugs to Receive Expedited Reviews Under National Priority Voucher Program
