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Guidance Documents/Guidance-Document/Providing Regulatory Submissions in Electronic Format -- Standardized Study Data

Providing Regulatory Submissions in Electronic Format -- Standardized Study Data

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

June 22, 2021

January 3, 2022

Center for Drug Evaluation and Research

814b3542-7010-4e11-9dfa-23b248ce9cbf

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