WASHINGTON — The Food and Drug Administration (FDA) has initiated a new priority review voucher program under the leadership of Commissioner Marty Makary, aimed at accelerating the drug approval process. This program, launched in June, offers a one- to two-month review timeline for drug applications, along with expedited feedback from reviewers.
To qualify, companies must demonstrate alignment with national health priorities, which include addressing public health crises, delivering innovative treatments, meeting unmet medical needs, relocating drug manufacturing to the U.S., and enhancing affordability. The response from the pharmaceutical industry has been overwhelmingly positive, with Makary noting at an internal meeting in August that the level of interest exceeded expectations, prompting immediate inquiries from potential applicants.
This initiative reflects a significant shift in FDA policy, emphasizing the agency’s commitment to fostering innovation and responsiveness in drug development. The implications for regulatory professionals, quality assurance teams, and sourcing departments are profound, as they must now navigate a landscape where speed and alignment with public health goals are paramount.
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