FDA unveils drugs to get expedited review in support of ‘national priorities’

The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive much faster review at the agency, part of an effort by the Trump administration to prioritize drugs that “support U.S. national interests.”

The nine medicines announced by fda This includes potential treatments for vaping addiction, deafness, pancreatic cancer and other conditions.

Many of the drugs will compete with high-priced drugs already on the US market.

But white Housechairman donald trump Highlights of the injectable infertility drug, Pergoveris, which is currently sold Europe for passing patients IVF treatment. Trump said FDA approval of the drug in the US would help reduce IVF costs for American families, one of his campaign promises.

Another drugmaker received special praise for expanding U.S. manufacturing of ketamine, the powerful anesthetic that has evolved into a trendy psychedelic treatment.

Under the program announced earlier this year, the FDA will aim to decide whether to approve drugs in one to two months, an unprecedented speed given the thorough safety and effectiveness reviews conducted by agency scientists.

The FDA’s accelerated approval program typically issues decisions in six months for drugs that treat life-threatening diseases. Regular medication review takes approximately 10 months.

Since arriving at the agency, FDA Commissioner Dr. Marty Macri has suggested the agency could dramatically speed up approval for some high-priority drugs, pointing to the shortened process used to authorize the first COVID-19 vaccines under Operation Warp Speed.

Many aspects of the so-called Commissioner’s National Priority Voucher Program overlap with older FDA programs. But the broad criteria for awarding vouchers give McCreary and other FDA officials unprecedented discretion in deciding which companies will benefit from expedited review.

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