Emily Statham

Emily Statham is an associate in the firm’s Washington, DC office where she is a member of the Food, Drug, and Device Practice Group. She advises pharmaceutical, biotechnology, medical device, food, and animal health companies on a variety of regulatory and compliance issues.

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FDA Releases Draft Guidance on Electronic Systems, Records, and Signatures in Clinical Investigations

By Wade Ackerman, Scott Cunningham, Paula Katz, Julia Post, Christina Kuhn & Emily Statham on April 4, 2023

Posted in FDA

On March 15, 2023, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (2023 Draft Guidance). The 2023 Draft Guidance revises the draft guidance for industry the Agency issued in June…

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