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  • jwgilbreath

FDA CDER NextGen Portal Update

Hello all!


I have been communicating with one of the FDA help lines for made clarity related to the CDER NextGen portal. The representative informed me that the use of the portal is optional. A third-party company can be used as your contact person as well. I assume that the third party solutions are looking into how they can help with the process of communication through the portal. I recommend that you work with them if you are signed up to use a tool.


I can say that looking at the reference guide I noted in my previous post discussed the upload using XML or JSON type of files. These are electronic formats that, I would assume that, if you are not using a third party solution, you will not be able to transfer these type data feed files. It appears you would have to manually enter much of the information about the drugs in question and at the end upload a file such as PDF or Excel type file. I have to say this seems error prone (I.e., human error of entry).


Well, if you are NOT planning on using the portal, I did ask the FDA how they would communicate with the sites. The individual informed me they would use whatever methods they have already been using (I.e., I would assume communication via snail mail maybe?).


If I hear more info regarding this topic I will share.


Thanks,


Jay G.

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