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Re: pgsd post# 444034

Tuesday, 02/15/2022 7:55:51 AM

Tuesday, February 15, 2022 7:55:51 AM

Post# of 705708
If they are waiting for new FDA guidelines being implemented then we have to wait for any new comments to come in first

https://www.foley.com/en/insights/publications/2021/12/fda-draft-guidance-real-data-evidence-regulatory

FDA recommends that stakeholders submit any comments on the Draft Guidance by March 8, 2022 through this docket.



then these comments need to be addressed all in all we can expect RWE guidance after the summer or worse by the end of 2022. But again we have bene waiting for RWE for years
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