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The U.S. Food and Drug Administration said on Tuesday it is launching a program under which its commissioner can issue vouchers to companies to shorten their review time for a drug application to 1-2 months from the typical timeline of about 10-12 months.
The US Food and Drug Administration announced a new national priority voucher plan that aims to cut drug review times to one to two months for companies it says are backing national interests.
(Reuters) -The U.S. Food and Drug Administration on Tuesday announced that it will issue a new priority review voucher to drug developers to shorten review time from about 10-12 months to one-two months.
FDA Commissioner Marty Makary faces declining staff morale as he remakes the agency.
The FDA is launching a program to reward companies with accelerated drug review and speedy agency feedback, if their actions align with the FDA's national health priorities.
While some compounding pharmacies have stopped making alternatives to Wegovy and Zepbound since shortages were declared over, others are continuing and pushing regulatory boundaries.
Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and "unleash AI."