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Cloud Computing 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

Hogan Lovells

Electric boogaloo: FDA releases sequel to 2003 guidance on use of electronic records and electronic signatures in clinical...

Hogan Lovells on

On 21 June 2017, FDA announced the availability of a new draft guidance titled "Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 — Questions and Answers." The draft guidance is...more

Sheppard Mullin Richter & Hampton LLP

The Impact of Cloud Computing on FDA's Regulation of Medical Products

The following blog article is drawn from the upcoming book Cloud Computing Deskbook, which is set to be released by Thomson Reuters West next summer. Cloud Computing Deskbook covers the legal and regulatory aspects of cloud...more

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