Welcome to Insider issue #11.

And welcome to the 116 new life science professionals who joined last month.

Today we’re dissecting the enhanced approach to analytical procedure development (originally mentioned at a high level in ICH Q12) that was presented in the draft of ICH Q14 in 2022. The draft describes the benefits of using elements of the enhanced approach, and we present a framework for deciding if it’s suitable for your organization, and if so, how to implement it.

On the device side, we’re doing a deep dive into FDA’s proposed framework for human factors information in device submissions, which was outlined in a draft guidance issued in December of 2022.

Lastly, we break down and draw lessons from a recent Warning Letter to a generic drugmaker over GMP and laboratory control issues.