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flipper44

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Re: flipper44 post# 408181

Sunday, 10/10/2021 6:04:13 PM

Sunday, October 10, 2021 6:04:13 PM

Post# of 703841
It was September 29. https://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents

So these two guidance drafts came out one day apart.

Biologics Benefit-Risk Assessment for New Drug and Biological Products Draft 9/29/2021

Real World Data/Real World Evidence Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products 9/28/2021
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