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. FDA stated that the firm received 96 U.S. Finally, FDA said in a Warning Letter that a Clinical Investigator, Anish S. Terragene S.A.,
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