I know it's been a while since my last post...the holidays plus traveling a lot for work! So, the FDA did puboish new guidance in...

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!! Remember we are about to enter into the “stabilization period” established by the FDA for DSCSA compliance. This is November...

Hello all! I'm attending the HDA traceability Seminar. Very interesting information. A couple FDA representatives are at the Seminar. ...

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...

Hello all! Previously, I gave an overview of DSCSA current state. Well changes are coming that will impact dispensers! Most of the...

So, let's briefly discuss a few matters related to how your site should be in compliance with DSCSA now. Changes for the future will be...

So, some of you may wonder why the Drugs Supply Chain Security Act (DSCSA) was passed through legislation. Nationally it was recognized...