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 52

FDA Compliance Clinical Trials Clinical Trials Compliance 52

XTalks

DECEMBER 9, 2024

Notably, the FDA can now mandate that confirmatory trials begin before approval, ensuring proactive validation of clinical benefits. The draft also formalizes withdrawal procedures for non-compliance, including delayed studies or failure to confirm benefits.

Clinical Trials 105

Clinical Trials Clinical Trials Compliance Trials 105

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 59

Manufacturing Production Drugs Contract Manufacturing 59

XTalks

JANUARY 8, 2025

In manufacturing, an AI-based system assessing drug vial fill levels must be complemented by independent quality control measures to ensure compliance. Non-compliance can arise if training data is not representative or if development lacks transparency.

Development 105

Development Drugs Compliance Clinical Trials 105