By Fineline Cube 
The U.S. Food and Drug Administration (FDA) this week announced the launch of the Commissioner’s National Priority Voucher (CNPV), a new initiative allowing pharmaceutical companies to participate in an innovative priority review program. The CNPV program will drastically reduce new drug review times from the standard 10–12 months after submission of a final marketing application to just 1–2 months.
Program Structure
The CNPV process will assemble a cross-functional team of experts from various FDA offices for a consolidated review, replacing the traditional sequential approach through multiple FDA divisions. Clinical data will be evaluated by a multidisciplinary team of physicians and scientists, who will conduct a pre-review of submitted materials and hold a one-day, tumor board-style meeting for assessment.
Eligibility and Objectives
In the program’s first year, the FDA plans to issue a limited number of CNPVs to companies meeting U.S. national interest priorities. These include addressing a U.S. health crisis, providing more innovative treatments for Americans, filling unmet public health needs, and strengthening domestic drug manufacturing capacity and securing supply chains.
Mechanism and Requirements
The CNPV can be assigned to a specific investigational drug from a company or granted as an unassigned voucher, allowing the company to decide which drug development program to apply it to. Eligible companies must submit Chemistry, Manufacturing, and Controls (CMC) data and draft labeling at least 60 days before filing the final application. The FDA may grant accelerated approval if legal requirements are met while maintaining enhanced communication with the company throughout the review process.-Fineline Info & Tech