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  • jwgilbreath

DSCSA—CDER NextGen Portal. Follow up

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 tool especially if the FDA sends you a letter, email, etc requesting that you investigate an medication you may have purchased that may be suspect/illegitimate.


The portal ALSO can be the place you go on and submit an FDA form 3911 for when you have determined a product you bought is illegitimate. This is the cases where YOU are the one that initiates the investigation due to red flags.


FDA will still accept a completed FDA form 3911s at drugnotifications@fda.hhs.gov .


In the past they have also they would accept responses sent by them to you via the original way such as email. There preferred for both of the situations above is to use CDER NextGen Portal though.


As I've stated in previous post, if you are using a third party solution for DSCSA work with them regarding the communications with FDA. Maybe their tool has a process built in that makes the process easier such as documenting how the investigation is conducted? Maybe the tools can help you complete an FDA form 3911? Again, discuss these things with the third party solution.


Thanks!


Jay G

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