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FDA Compliance

Manufacturing

FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. If FDA wanted to create that impression, it likely succeeded. They have great impact on most companies that receive them.

Manufacturing

Manufacturing Production Drugs FDA Compliance

FDA Flips It and Reverses It: FDA Withdraws HHS Withdrawal of UDI Guidance

FDA Law Blog

JUNE 9, 2021

Koblitz — While typically, FDA is responsible for setting forth its own agenda and enforcing compliance with its own regulations, the Trump Administration’s HHS, on its way out the door in late 2020 , took the unusual steps of withdrawing an important FDA Compliance Policy Guide, “Marketed Unapproved Drugs – Compliance Policy Guide Sec.

Compliance

Compliance Drugs Production Marketing

FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Flips It and Reverses It: FDA Withdraws HHS Withdrawal of UDI Guidance

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