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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

Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared with prior releases in 2023). Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials.

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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