FDA Opts To Keep Unapproved Drug Program Axed By Trump

By Adam Lidgett (May 28, 2021, 4:41 PM EDT) -- The U.S. Food and Drug Administration has withdrawn what it called "a legally and factually inaccurate" Trump administration policy seeking to end a program blamed for causing big price hikes on drugs that have been on the market for many decades.

In a notice published in the Federal Register on Thursday, the FDA said it was undoing a November decision by former President Donald Trump to jettison the FDA's Unapproved Drugs Initiative, or UDI, which encouraged drugmakers to invest in proving the safety and effectiveness of medicines that have been sold without formal approval for decades.

The Federal Register notice said that the November decision...

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