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Data Management Information Technology Food and Drug Administration (FDA)

Foley & Lardner LLP

FDA Clinical Investigations: New Guidance on Electronic Systems

Foley & Lardner LLP on

On October 2, 2024, the U.S. Food and Drug Administration (FDA) released guidance in a question and answer format regarding the use of electronic systems, electronic records, and electronic signatures in clinical...more

Burr & Forman

FDA Releases New Draft Guidance Regarding Clinical Trial Data Monitoring Committees

Burr & Forman on

The U.S. Food & Drug Administration (FDA) released a new proposed draft guidance in February that would change the FDA’s outlook on the engagement of a data monitoring committee (DMC) in clinical trials. Originally...more

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