The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical.
Food and Drug Administration FDA issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers. Draft Guidance revamps earlier recommendations from 2017 regarding requirements of 21 CFR Part 11.
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On March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical.
This exploratory study of a multiplatform randomized trial investigating the effects of therapeutic-dose heparin in early-pandemic hospitalized COVID-19 patient