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101. Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components

nlm:nlmuid-101734377-pdf

102. S3A guidance: note for guidance on toxicokinetics : the assessment of systemic exposure in toxicity studies : focus on microsampling : questions and answers

nlm:nlmuid-101734186-pdf

104. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception

nlm:nlmuid-101719973-pdf

108. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101720001-pdf

110. Unique device identification: policy regarding compliance dates for class I and unclassified devices : immediately in effect guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101720053-pdf

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