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flipper44

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Tuesday, 10/26/2021 4:21:02 PM

Tuesday, October 26, 2021 4:21:02 PM

Post# of 705241
Another recent Draft Guidance: October 21, 2021

Data Standards for Drug and Biological Product Submissions Containing Real-World Data
Guidance for Industry

https://www.fda.gov/media/153341/download

Add that to the two published at the end of September.

https://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents

Also, these two guidance drafts came out one day apart.

Biologics Benefit-Risk Assessment for New Drug and Biological Products Draft 9/29/2021 (includes guidance regarding external controls)

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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