To all my readers – have a happy holiday season and a very happy, healthy and prosperous New Year.  The Lachman blog will be taking a break over the holiday (unless something extremely urgent occurs) and I hope that all of you will join me back in the New Year as we follow the ever-changing landscape of FDA regulatory science, enforcement and policy.  This past year has been had many twists and turns (some of which we are still trying to figure out).  Some FDA guidance and proclamations in 2013 have provided us with straightforward advice that we need to apply to our thinking and behavior, while others have created great controversy or have left us in the industry scratching our heads.  Let us hope that 2014 provides further resolution of some of the confusion and clarifies some of the unclearness so that we can work together with our colleagues at the FDA in a more effective and efficient manner.

Enjoy your families over the next couple of weeks and take a well-deserved break.  See you in 2014!