Sunday, January 7, 2024

FDA finalizes minimal risk rules for IRBs

 Not sure how this varies from existing minimal risk waivers for irb, which go back to 1990s.   Maybe just expanding them to fda domain where they were oddly missing till now

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https://www.jdsupra.com/legalnews/fda-issues-final-rule-permitting-irb-9116244/

https://www.govinfo.gov/content/pkg/FR-2017-07-25/pdf/2017-15539.pdf

https://www.fdanews.com/ext/resources/files/2017/07/07-24-17-IRB-Waiver.pdf?1519353957


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