Clinical Research, FDA Compliance and Laboratories

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

FDA Law Blog: Biosimilars

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. Dextrum Laboratories Inc. Finally, FDA said in a Warning Letter that a Clinical Investigator, Anish S. Shah, M.D.,

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

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