FDA Aims To Reduce Drug Application Review Time With New Voucher Program

The FDA Commissioner will issue vouchers that drug developers may redeem to participate in a program that will shorten its review time from about 10-12 months to 1-2 months after the company’s final drug application.

The U.S. Food and Drug Administration (FDA) on Tuesday announced it is launching a voucher program to accelerate reviews of drug applications.

The FDA Commissioner will issue vouchers that drug developers may redeem to participate in a program that will shorten the review time from approximately 10-12 months to 1-2 months after the company submits its final drug application.  

The expedited process will convene experts from FDA offices for a team-based review, rather than using the standard review system, where a drug application is sent to numerous FDA offices.

FDA Commissioner Marty Makary said that the program will allow companies to submit the “lion’s share” of the application before a clinical trial is complete.

“The ultimate goal is to bring more cures and meaningful treatments to the American public,” he added.

According to the current plan, the agency will distribute a limited number of vouchers to companies aligned with the U.S.’ national priorities in the first year, the FDA stated, without naming any specific companies.

The companies should be either addressing a health crisis in the U.S., delivering more innovative cures, addressing unmet public health needs, or increasing domestic drug manufacturing as a national security issue.

To qualify for the expedited review program, companies must submit the chemistry, manufacturing, and controls (CMC) portion of the application at least 60 days before submitting the final application. Companies must also be available for ongoing communication with the agency.

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, the FDA said.

The agency may increase the number of vouchers it gives to companies after the first year, it added.

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