A gene therapy for hearing loss. A drug that helps people quit e-cigarettes or vaping. An anesthetic whose main ingredient will be manufactured in the U.S. These are among the first nine therapies selected by the FDA for a new program that will accelerate regulatory review of products that meet certain national interest goals.
Each product selected for this program was awarded what’s called a Commissioner’s National Priority Review Voucher (CNPV). Standard drug review is 10 to 12 months. The vouchers from this pilot program shorten reviews to one-to-two months. When the FDA announced the new CNPV program in June , it was unclear how products would be selected for a voucher. There’s more detail now.
The FDA’s Office of New Drugs is comprised of eight review offices designated by the