Name Size Creator Creation Date Labels Comment  
PDF File StudyDataTechnicalConformanceGuide_v4.8.1_October_2021_1.pdf 893 kB Angelo Tinazzi Dec 02, 2021 07:35
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PDF File Simplified TS File Creation Guide_Final.pdf 852 kB Angelo Tinazzi Dec 02, 2021 07:40
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PDF File FDA_UCM332468_BIOM_TCG.pdf 697 kB Angelo Tinazzi Nov 28, 2018 02:55
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PDF File BIMO V2 Conformance Guide Submission of NDA BLA Content for BIMO Final 07.27.20 (002) (002) (1).pdf 556 kB Angelo Tinazzi Dec 02, 2021 07:38
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PDF File Standardized-Format-for-Electronic-Submission-of-NDA-and-BLA-Content-for-the-Planning-of-Bioresearch-Monitoring-(BIMO)-Inspections-for-CDER-SubmissionsGuidance-for-Industry.pdf 110 kB Angelo Tinazzi Dec 02, 2021 07:38
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PDF File FDA_UCM332466_Inpsections.pdf 110 kB Angelo Tinazzi Nov 28, 2018 02:54
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