The U.S. Food and Drug Administration (FDA) announced its Commissioner’s National Priority Voucher (CNPV) program.
What Happened: The FDA aims to modernize its regulatory framework to meet emerging public health needs.
Drug developers may redeem the new voucher to participate in the FDA’s novel priority program, which shortens the review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission.
As per the press release on Tuesday, the new CNPV process convenes experts from FDA offices for a team-based review rather than the standard review system for a drug application sent to numerous FDA offices.
Clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a 1-day “tumor board style” meeting.
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Why It Matters: “Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies…,” said FDA Commissioner Marty Makary. “As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a 1-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”
In the program’s first year, the FDA plans to award a limited number of vouchers to companies aligned with U.S. national priorities.
In addition to receiving the benefits of this program, the agency may also grant an accelerated approval if the product for which the voucher is used meets the applicable legal requirements for accelerated approval.
To qualify, sponsors must submit the chemistry, manufacturing, and controls (CMC) portion of the application and the draft labeling at least 60 days before submitting the final application.
The FDA reserves the right to extend the review window if the data or application components submitted are insufficient or incomplete, if the pivotal trial(s) results are ambiguous, or if the review is particularly complex.
Vouchers can be directed by the FDA towards a specific investigational new drug of a company or be granted to a company as an undesignated voucher, allowing a company to use the voucher for a new drug at the company’s discretion and consistent with the program’s objectives.
This program aims to accelerate the drug review process for companies aligned with U.S. national priorities.
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