
FDA unveils drugs to receive expedited review in support of ‘national priorities’
On Oct. 16, 2025, the Food and Drug Administration (FDA) announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to prioritize medicines the Trump administration deems as “supporting U.S. national interests.”
The nine medicines announced by the FDA include potential treatments for vaping addiction, deafness, pancreatic cancer and other conditions. Several of the drugs would compete with higher-priced drugs already on the U.S. market.
Under the program announced earlier this year, the FDA will aim to decide whether to approve the drugs in one to two months, an unprecedented pace for the in-depth safety and effectiveness reviews performed by agency scientists.
FDA’s accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.
Many aspects of the so-called Commissioner’s National Priority Voucher program overlap with older FDA programs. But the broad criteria for awarding the vouchers gives FDA Commissioner Dr. Marty Makary and other FDA officials unprecedented discretion in deciding which companies will benefit from the sped-up reviews.
Tags:
Source: Associated Press
Credit:
