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62. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101734317-pdf

65. M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

nlm:nlmuid-101734078-pdf

66. Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719889-pdf

72. Nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV): testing, product disposition, and donor deferral and reentry

nlm:nlmuid-101719989-pdf

73. Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719987-pdf

76. Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff

nlm:nlmuid-101719888-pdf

79. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications

nlm:nlmuid-101704838-pdf

80. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers

nlm:nlmuid-101734070-pdf