51ÁÔÆæ

Listen to hear 51ÁÔÆæ's Director of Regulatory Affairs, Jordan Elder, review the key differences regarding the new Quality Management System Regulation (QMSR) final rule and the current Quality System Regulation...

The FDA is cracking down on labeling for drug products that will require companies to reevaluate and make changes to new and existing products if they wish to stay in...

In this episode of 51ÁÔÆæ Radio®, host Brandon Miller is joined by Rod Mell, Executive Head – Life Science Consulting at 51ÁÔÆæ, as well as Jordan Elder, Director of Regulatory...

In this episode of 51ÁÔÆæ Radio®, host Brandon Miller is joined by Anita Michael, Executive Pharma Compliance Expert & Principal Consultant and Rona LeBlanc-Rivera, Director, Regulatory Affairs both at Regulatory...

This presentation provides a comprehensive overview of the FDA’s medical device pre-submission process, a critical step for manufacturers seeking to efficiently bring safe and effective devices to market. This session...

What is a pre-determined change control plan (PCCP)? The FDA recently released a final guidance on regulating AI-enabled medical devices that focuses on how manufacturers can modify these devices after...