All articles tagged with #priority review vouchers
Originally Published 2 months ago — by Fierce Biotech
The FDA has issued its first nine priority review vouchers to expedite the approval process for certain drugs and therapies, including Regeneron's gene therapy for hearing loss, with the aim of reducing approval times from 10-12 months to 1-2 months, focusing on public health priorities and affordability.
Originally Published 2 months ago — by statnews.com
The FDA announced the first nine recipients of the Commissioner’s National Priority Review vouchers, which expedite drug reviews for products aligned with national health priorities. Notably, EMD Serono received a voucher after agreeing to lower prices for its fertility drugs, including Pergoveris, in a move highlighted by President Trump. The program aims to incentivize companies to develop and provide access to important medications.