The purpose of this Web Site is to share with the FDA regulated community recent activities within the FDA and the USP that you may find of interest.

This will include, in particular, Warning Letters and their application to your various activities.  It will also focus upon new drafts of Guidance for Industry and various upcoming regulations.

Since the USP plays a significant role in pharmaceuticals and biotechnology, their various activites will be focused upon and include proposed and new USP offerings within the General Chapter and General Information Chapter areas. 

Discussions to include new variations on the “old” and completely new documents will be highlighted.

A list of upcoming webinars and seminars that I will be providing will also be provided as well as a list of topics for In-House training.

Finally, I welcome your comments.