The 20-Day Window Catch – How Will It Play Out? and Other Questions

The unprecedented length of the government shutdown has a lot of people scratching their heads about lots of things.  From a personal perspective, I have heard that FDAers are still getting paid (Commissioned Corps and civil servants) but the unknown is, for how long?  When will the user fee money really run out?  Has FDA been able to use the money that they collected for the applications submitted between October 1,

Happy Holidays from Us to You!

To all of our 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 starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,

Did Someone Forget User Fees?

I just read the Association for Accessible Medicines’ (AAM) White Paper entitled “Ensuring the Future of Accessible Medicines in the U.S.,  Avoiding Shortages & Ensuring Competition for America’s Patients” (here) that is being entered into the record at the FDA-sponsored meeting  Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions held on November 27th in Washington DC.