By MATTHEW PERRONE
WASHINGTON (AP) — The Food and Drug Administration on Thursday 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.”
Related Articles
USC won’t sign Trump compact on federal funding Trump announces a deal with a manufacturer to make a common fertility drug cheaper for IVF patients Questions raised on Qatar at Idaho Air Force base Ex-Trump national security adviser Bolton charged in probe of mishandling of classified information States are redistricting to help one party but sometimes the move can backfireThe 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.
At the White House, President Donald Trump highlighted the injectable infertility drug, Pergoveris, which is currently sold in Europe for patients going through IVF treatments. Trump said FDA approval of the drug in the U.S. would help lower IVF costs for American families, one of his campaign pledges.
Another drugmaker received the specialty review to expand U.S. manufacturing of ketamine, the powerful anesthetic that has grown into a trendy psychedelic treatment.
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.
Since arriving at the agency, FDA Commissioner Dr. Marty Makary has suggested the agency could dramatically speed up approvals for certain high-priority drugs, pointing to the truncated 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 the vouchers gives Makary and other FDA officials unprecedented discretion in deciding which companies will benefit from the sped-up reviews.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Hence then, the article about fda unveils drugs to receive expedited review in support of national priorities was published today ( ) and is available on Los Angeles Daily News ( Middle East ) The editorial team at PressBee has edited and verified it, and it may have been modified, fully republished, or quoted. You can read and follow the updates of this news or article from its original source.
Read More Details
Finally We wish PressBee provided you with enough information of ( FDA unveils drugs to receive expedited review in support of ‘national priorities’ )
Also on site :