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FDA Federal Registry Notice:
1. Docket Citation 85 FR 67355, Docket No. FDA-2020-N-1806 (Federal Register :: Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide Developmental and Reproductive Toxicology: Version 1.1)
Pilot Results

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name	SENDIG-DARTv1.1 FFU Shared Learnings.pptx
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name	SENDIG-DARTv1.1 FFU Participant Experience Feedback.pptx
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FDA Feedback
and Submission packages as provided by each participant (Anonymized / Redacted)
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name	DART Pilot FDA Reviewer Feedback - Compiled.xlsx
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name	KickStart feedback Compiled (1).xlsx
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Reviewer Feedback: PTOX Study Review Document KickStart Session Documents: Data Fitness Summary KickStart Session Report Outputs – Janus Outputs - SEND Explorer	Submission Documents (anonymized / redacted): SEND Datasets (.xpt, .csv, or .xlsx) nsdrg define-xml Study Report Study Protocol
Participant zip files (6 participants)
DART FFU (P1).zip	DART FFU (P2).zip
DART FFU (P3).zip	DART FFU (P4).zip
DART FFU (P5).zip RptAudited_Redacted_CDISC (P5)-Part2.zip RptAudited_Redacted_CDISC (P5)-Part3.zip	DART FFU (P6).zip

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