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Draft FDA submission FAQs #385

Closed tiwa1154 closed 1 month ago

tiwa1154 commented 3 months ago

run through CBER CDER for feedback. "Crandall, Heather" Heather.Crandall@fda.hhs.gov, "Resnick, Jonathan" Jonathan.Resnick@fda.hhs.gov chris.mccormick@fda.hhs.gov, "Donaldson, Eric" eric.donaldson@fda.hhs.gov, Luis luis.santana-quintero@fda.hhs.gov, mark.gray@fda.hhs.gov,

tiwa1154 commented 3 months ago

show to Ginny at the meeting

tiwa1154 commented 2 months ago

Sent to FDA for review: Action items for next revision:

tiwa1154 commented 2 months ago

Received feedback from FDA, need to send to eCTD