Hello all! I have been communicating with one of the FDA help lines for made clarity related to the CDER NextGen portal. The...

Hello all! So, FDA has added to their Centers for Drug Evaluation and Research (CDER) internet site (I.e., their "CDER NextGen" Portal). ...

Hello all! So one thing that has been asked of me is the following: How does DSCSA affect ambulance restocking/replenishment? Many of...

Hello all! I know I have been bombarding you with info regarding DSCSA last few days!  I attended a Seminar that was solely discussing...

Hello all! I decided to put this blog here sort of as a place holder. This is just a reminder that the FDA has decided to extend the...

Sorry everybody.... I've been very tied up at work lately so have not been focusing on the blog. Decided to jump on and post a very,...

Welcome back to the blog! Let's discuss one of the core reasons why DSCSA was formulated ...suspect and illegitimate products. FDA has...