XTalks

DECEMBER 9, 2024

The new framework allows the FDA to require confirmatory trials to be underway before or shortly after approval, potentially reducing the time to confirm a therapys clinical impact from several years to as little as two or three years.

Clinical Trials 105

Clinical Trials Clinical Trials Compliance Trials 105

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

FDA Law Blog

JANUARY 1, 2024

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. If FDA wanted to create that impression, it likely succeeded. 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

Last year, Sanofi partnered with Formation Bio and OpenAI to introduce Muse, an AI-powered tool designed to accelerate patient recruitment for clinical trials. The possibilities of applying AI in drug development are vast and varied.

Development 105

Development Drugs Compliance Clinical Trials 105