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Clinical Research

FDA Compliance

Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management

ProRelix Research

DECEMBER 28, 2023

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

FDA Compliance

FDA Compliance Compliance Clinical Trials Clinical Trials

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

Manufacturing

Manufacturing Production Drugs FDA Compliance

Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management

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

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