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

This shift not only prioritizes patient safety but also ensures that ineffective treatments are identified more quickly.

Clinical Trials 105

Clinical Trials Clinical Trials Compliance Trials 105

FDA Law Blog

JANUARY 1, 2024

If FDA wanted to create that impression, it likely succeeded. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators. They have great impact on most companies that receive them.

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59

Cloudbyz

AUGUST 19, 2024

They require the most stringent regulatory controls, including premarket approval (PMA), which involves rigorous testing and clinical trials to demonstrate safety and effectiveness before they can be marketed. What is the process for conducting clinical trials for medical devices?

Compliance 52

Compliance Manufacturing Regulation Marketing 52

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