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How the US Election May Affect the FDA Regulation of Life Sciences Products – Key Areas to Watch

The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, has prompted many in the life sciences industry to question how this political shift...more

FDA Reinstates Unapproved New Drug Initiative

In a May 27 Federal Register notice, the US Department of Health and Human Services (HHS) announced the reinstatement of the Unapproved Drugs Initiative, the FDA’s compliance policy governing marketed unapproved drugs. The...more

HHS Ends FDA’s Unapproved Drugs Initiative – At Least For Now

In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI). ...more

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