We filed our Diversity Plan in Mod 5 section 5.3.5.1 Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication. We had already had our EOP2 meeting right around the time the FDA issued their Draft guidance in April 2022 so we ended up submitting about a year later despite our Phase 3 study already being underway.
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Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
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Original Message:
Sent: 02-Feb-2024 17:43
From: Kourtney Holloway
Subject: Diversity Plans
Hello all,
There is currently a draft guidance on the inclusion of a diversity plan in INDs and marketing applications; Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethical Populations in Clinical Trials. The need for a diversity plan to be included in an application is a relatively newer request. The guidance above suggests a diversity plan be placed in a meeting package no later than EOP2. My question is for applications that are more advanced, i.e., being prepared for NDA submission, where in the eCTD would a diversity plan be placed that describes a plan for the last Phase 3 study conducted for said program?