Rebecca Dandeker

Rebecca Dandeker

Morgan Lewis

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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

6/11/2021  /  Department of Health and Human Services (HHS) , Enforcement Programs , FDA Approval , Food & Drug Regulations , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Prescription Drugs

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

12/2/2020  /  Department of Health and Human Services (HHS) , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs , Retail Sales
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