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112. Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics: guidance for stakeholders and Food and Drug Administration staff

nlm:nlmuid-101734132-pdf

113. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101713224-pdf

114. Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components

nlm:nlmuid-101720003-pdf

115. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

nlm:nlmuid-101720038-pdf