Happy multi-generation family holding Thanksgiving turkey together at dining table.

Hope at This Time of Giving Thanks

Just look around, watch the television, read the newspaper, and what do you see?  Seems like very few reasons to be thankful.  School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth.  Climate change is threatening the future of our children, and the environmental controls have been set back 50 years as the oceans continue to rise,

Q&A Document Issued for Manufacturing Facility Information

The FDA released a final Q&A document titled “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers” that provides answers to some of the most frequently asked and problematic questions raised by incomplete manufacturing, testing, packaging, etc.

The document provides specific guidance on what, where, and how to list such information in the 356h and in the relevant modules of the application. 

Just Say No! Not a Good Idea for a Testing Lab

In a short Warning Letter issued by the FDA on August 29, 2019, the Agency informed a China-based testing firm that, because it refused inspection, that FDA would withhold approvals of any ANDA or NDA in which it was cited as a testing laboratory.  The FDA takes refusal of inspection very seriously and the impact on NDA or ANDA sponsors (or,