Hello all…   As you may have already heard, the FDA has announced more exemptions for authorized trading partners. For this post I will...

Hello all! So, as a follow up regarding the CDER NextGen Portal: As I stated in an earlier post, the portal is used as a communication...

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). ...

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...