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 Compliance Clinical Trials Clinical Trials 52

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

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. They have great impact on most companies that receive them.

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59

Cloudbyz

AUGUST 19, 2024

Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare. This is where the importance of stringent safety processes, robust systems, and comprehensive regulations comes into play. What is the Medical Device Safety process?

Compliance 52

Compliance Manufacturing Regulation Marketing 52