BioPharma – USA/Europe/Asia Regulatory Updates, April 2024
USA Content and Format of Composition Statement and Corresponding ...
A simple Glance of Log Rank Test in Survival Analysis for Clinical Trial Data Analysis
In clinical trials, especially in cancer clinical trials, at least...
Sterilization Regulatory Requirements and Supporting Standards
Sterilization of medical devices is a critical process integral to...
Responsibilities for Medical Devices Vigilance Reporting
Medical devices are regulated differently across the globe. Each c...
US FDA Traditional 510(K) Submission – A Step by Step Process
In the United States, medical devices are regulated under the Fede...
US FDA Medical Device Labeling Requirements
What Is Medical Device Labeling?
According to the FDA, medical dev...
