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Containment

FDA Compliance

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

FDA Law Blog

JANUARY 1, 2024

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Two device manufacturers received Warning Letters for QSR violations (QSR is FDA’s label for cGMP requirements applicable to medical device manufacturers).

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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