FDA End-of-Year Release of Warning Letters Impresses (or Depresses)
FDA Law Blog
JANUARY 1, 2024
We are unable to determine whether the number of such Warning Letters issued during the entire year represents a significant increase over 2022. 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.
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