
Kalawin
The U.S. Food and Drug Administration has revealed plans to launch a national priority voucher program aimed at reducing the drug review time period for selected manufacturers.
Under this new plan, drug review times will be shortened to just 1 to 2 months, a significant decrease from the current 10 to 12 months.
The new process involves a collaborative effort from various FDA experts who will work as a team to review applications instead of the traditional method, where applications are sent to multiple departments within the FDA.
The agency also added that it may also provide accelerated approval if the product qualifies under the legal standards set for such approvals.
“By adopting a straightforward approach, the national priority review plan will permit companies to submit most of their drug applications before finishing clinical trials, which will help eliminate inefficiencies. Our primary goal is to deliver more effective treatments and cures to the public,” FDA Commissioner Marty Makary said in a statement.
This initiative focuses on speeding up the drug review process for companies that align with national priorities, the agency added.
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