Hello all, On June 12, 2024, the FDA announced DSCSA exemptions for certain types of dispensers (i.e., “small dispensers”) until November...

Hello All! We are coming up to the midpoint of the FDAs stabilization period allowed for the industry to prepare for DSCSA compliance. ...

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!! With the FDA information about stabilization period for DSCSA in mind.... Are you pushing forward with your plans to be fully...

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...