With few remaining unapproved drugs, researchers tell FDA its Unapproved Drugs Initiative is no longer effective
Back in May, the FDA decided to reverse a Trump-era decision to pull the agency’s controversial Unapproved Drugs Initiative, with the FDA citing “multiple legal and factual inaccuracies.”
But now a group of researchers from Harvard, funded by Arnold Ventures, raises new questions about why the UDI program might not be necessary in its current form.
Designed in 2006 as a way for the FDA to transition old drugs from unapproved to approved products, the agency sought to better ensure that unsafe products were removed from the market.
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