Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had approved an FDA guidance document on “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Guidance for Industry”. The guidance document was sent to OIRA on September 16th, 2024. This is a very fast turnaround for OIRA, indicating a high priority within the Administration.
As is the case with most guidance documents, this was not listed in the Spring 2024 Unified Agenda. The FDA did, however, publish a draft of this document in March of 2023. That draft did include one question (question #11 on page 15): “What are FDA’s requirements and recommendations regarding the use of security safeguards?”
Such cybersecurity ‘requirements’ may be covered in this blog when the guidance document is published.
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