Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

Has any of you worked with the FDA on a pre-submission where instead of full fledged clinical trials , FDA has agreed to work with the industry to generate registries and use the evidence analysis instead. If so, can you provide some background how did you go about this process.

thanks

Hi,
Do you know NESTcc? https://nestcc.org/
It's an MDIC/CDRH initiative that could be helpful.
If you need any added information, please feel free to contact me.
Kind regards,
Estelle Frappé
estelle.frappe@aetion.com

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Estelle FRAPPE
Director, Real World Solutions, MD&D
RUEIL MALMAISON
France
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Original Message:
Sent: 20-Jul-2022 02:17
From: Anonymous Member
Subject: REGISTRIES for Real World Evidence

This message was posted by a user wishing to remain anonymous

Hi,

Has any of you worked with the FDA on a pre-submission where instead of full fledged clinical trials , FDA has agreed to work with the industry to generate registries and use the evidence analysis instead. If so, can you provide some background how did you go about this process.

thanks