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

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

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