Clinical Research, FDA Compliance and Regulation

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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

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

Manufacturing

Manufacturing Production Drugs FDA Compliance

Clinical Research Informer

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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