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UC Comments on FDA's Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability (Docket No. FDA-2021-D-1214, December 9, 2021)

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comment letter, hhs, fda, human subjects research, institutional review boards, irb, common rule, clinical research

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UC Comments on FDA's&nbsp;Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability (Docket No. FDA-2021-D-1214, December 9, 2021)