WASHINGTON — WASHINGTON (AP) – Food and Drug Administration announced on Thursday the first round of experimental drugs that will receive significantly speeded up the review at the agency, part of an effort to prioritize drugs that the Trump administration considers “supportive of U.S. national interests.”
Nine Drugs Announced by FDA Include Potential Treatments vaping addictiondeafness, pancreatic cancer and other conditions.
Some of the drugs will compete with more expensive drugs already on the US market.
In the White House President Donald Trump highlighted the injectable fertility drug Pergoveris, which is currently marketed in Europe for patients undergoing IVF procedures. Trump said FDA approval of the drug in the United States would help lower IVF costs for American families, one of his campaign promises.
Another drugmaker has received a special assessment to expand drug production in the United States. ketaminea powerful anesthetic that has become fashionable psychedelic treatment.
Under the program announced earlier this year, the FDA will aim to decide whether to approve drugs within one to two months, an unprecedented pace for in-depth safety and effectiveness reviews conducted by agency scientists.
The FDA's Accelerated Approval Program typically makes decisions within six months on drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.
From the moment of arrival at the agency, FDA Commissioner Dr. Marty Macari suggested the agency could significantly speed up approval of some high-priority drugs, pointing to the stripped-down process used to authorize the first COVID-19 vaccines under Operation Warp Speed.
Many aspects of the so-called Commissioner's National Priority Voucher The program overlaps with older FDA programs. But the broad criteria for issuing vouchers gives Macari and other FDA officials unprecedented latitude in deciding which companies will benefit from expedited inspections.
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