US FDA to shorten review time for drug developers under new voucher program
The U.S. FDA is launching a program under which its commissioner can issue vouchers to companies he finds are aligned with national priorities to shorten their review time for a drug application to one to two months from the typical timeline of about 10-12 months.
The regulator said on Tuesday that the commissioner would determine whether a company aligns with health priorities such as delivering innovative medicines, addressing a health crisis or unmet public health needs, and increasing domestic drug manufacturing.
The FDA will issue a limited number of vouchers starting in 2025. The vouchers will be non-transferable and have to be used within two years. After a one-year pilot phase, the regulator may increase the number of vouchers it gives to companies.
To qualify, companies must submit the chemistry, manufacturing, and controls (CMC) portion of their application at least 60 days before submitting the final application, the FDA said.
FDA Commissioner Marty Makary said the program will allow companies to submit “the lion’s share” of an application before a clinical study is completed, which he said can reduce inefficiencies.
The new Commissioner’s National Priority Voucher (CNPV) program will convene experts from the regulator’s offices for a team-based review, instead of using the standard review system, where a drug application is sent to numerous FDA offices.
The program aims to accelerate the drug review process while maintaining the FDA’s rigorous standards for safety, efficacy and quality, the regulator said.
