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Name
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Size
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Creator |
Creation Date
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Labels |
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PDF File
StudyDataTechnicalConformanceGuide_v4.8.1_October_2021_1.pdf
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893 kB |
Angelo Tinazzi |
Dec 02, 2021 07:35 |
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Version 1 (current)
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893 kB |
Angelo Tinazzi |
Dec 02, 2021 07:35 |
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PDF File
Simplified TS File Creation Guide_Final.pdf
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852 kB |
Angelo Tinazzi |
Dec 02, 2021 07:40 |
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Version 1 (current)
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852 kB |
Angelo Tinazzi |
Dec 02, 2021 07:40 |
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PDF File
FDA_UCM332468_BIOM_TCG.pdf
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697 kB |
Angelo Tinazzi |
Nov 28, 2018 02:55 |
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Version 1 (current)
|
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
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556 kB |
Angelo Tinazzi |
Dec 02, 2021 07:38 |
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Version 2 (current)
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556 kB |
Angelo Tinazzi |
Dec 02, 2021 07:38 |
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Version 1
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556 kB |
Angelo Tinazzi |
Dec 02, 2021 07:36 |
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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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Version 1 (current)
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110 kB |
Angelo Tinazzi |
Dec 02, 2021 07:38 |
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PDF File
FDA_UCM332466_Inpsections.pdf
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110 kB |
Angelo Tinazzi |
Nov 28, 2018 02:54 |
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Version 1 (current)
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110 kB |
Angelo Tinazzi |
Nov 28, 2018 02:54 |
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