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  • jwgilbreath


Hello all!

So, FDA has added to their Centers for Drug Evaluation and Research (CDER) internet site (I.e., their "CDER NextGen" Portal). The update is related to the DCSCA. The FDA states that the DSCSA update to the site is be used to:

  • Confirm basic information and points of contact for trading partners

  • Notify trading partners when they have messages from the FDA

  • Enable trading partners to respond to FDA messages and upload documents

I know you pharmacy people are thinking "ok this is something new!" This site has already been in place, but the DSCSA section has been added. In the communication from the FDA, they have supplied a FAQ about the portal and a "how to" reference guide to sign into the portal.

The link to the communication is . If it will not pull up when you click on the link, copy and paste it into the address section of the internet search engine. Also, if you want to see the link to the FAQ here it is:

The link for the reference guide is:

When you read the information, I hope you do not become confused. There was one item that sort of stuck out at me...the FDA will email you if they want you to send something to them through the site. So, I was wondering how will they know your contact info? When you look at the reference guide document it is a tad confusing. It doesn't say that you must sign up or into the CDER portal. I think I "figured it out" but decided to email one of the help desks at FDA to ensure that I understood the process. I also asked them if they have a reference guide of how to sign up for CDER. The representative contacted me back via email and sent a handy reference guide and a process for signing in initially! Here are the references:

I personally think it would behoove you to go ahead and go into the system and create an account for your site. That way the FDA will have the correct contact info for you. When signing up for the process within the Portal you will need the DUNS number for your facility by the way.

I know this may be a new process for you, but I personally think the sooner you get into looking at this type of matter the better!!

Hopefully your stabilization period is going well!

Jay G.

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