The FDA is launching a National Priority Voucher program to accelerate reviews of certain new drug applications.
The agency will distribute a limited number of vouchers in the program’s first year to drugmakers “aligned with U.S. national priorities,” according to a June 17 news release. Drugmakers may use the vouchers to qualify for priority reviews, which aim to trim the process from 10 to 12 months to just one to two after a new drug application is submitted.
Instead of following the FDA’s traditional review process, the agency will assemble a multidisciplinary group of physicians and scientists from across its offices for team-based reviews. These groups will pre-review drug applications and convene for a one-day tumor board-style meeting. The FDA may grant an accelerated approval to new drug candidates as appropriate.
“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,” FDA Commissioner Marty Makary MD, said in the news release. “The ultimate goal is to bring more cures and meaningful treatments to the American public.”
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