Attachments

	Name	Size	Creator	Creation Date	Labels	Comment
	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	No labels		View
	Version 2 (current)	556 kB	Angelo Tinazzi	Dec 02, 2021 07:38
	Version 1	556 kB	Angelo Tinazzi	Dec 02, 2021 07:36
	PDF File FDA_UCM332466_Inpsections.pdf	110 kB	Angelo Tinazzi	Nov 28, 2018 02:54	No labels		View
	Version 1 (current)	110 kB	Angelo Tinazzi	Nov 28, 2018 02:54
	PDF File FDA_UCM332468_BIOM_TCG.pdf	697 kB	Angelo Tinazzi	Nov 28, 2018 02:55	No labels		View
	Version 1 (current)	697 kB	Angelo Tinazzi	Nov 28, 2018 02:55
	PDF File Simplified TS File Creation Guide_Final.pdf	852 kB	Angelo Tinazzi	Dec 02, 2021 07:40	No labels		View
	Version 1 (current)	852 kB	Angelo Tinazzi	Dec 02, 2021 07:40
	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	No labels		View
	Version 1 (current)	110 kB	Angelo Tinazzi	Dec 02, 2021 07:38
	PDF File StudyDataTechnicalConformanceGuide_v4.8.1_October_2021_1.pdf	893 kB	Angelo Tinazzi	Dec 02, 2021 07:35	No labels		View
	Version 1 (current)	893 kB	Angelo Tinazzi	Dec 02, 2021 07:35

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