As the Covington team discussed in a recent article, use of AI models in biopharma is on the rise, with use cases spanning the life cycle of drugs and biologics, including product development, manufacturing, and pharmacovigilance. Recently, FDA announced its own intentions to aggressively scale the use of AI
Continue Reading Could FDA Model Master Files Facilitate Use of Third-Party AI Models in the Drug Life Cycle?FDA
FDA Requests Comments on Substantial Proposed Changes to Data Standards
By Deepen Gagneja & Joe Franklin on
FDA has issued two Federal Register notices in under two weeks that seek comments on updates to FDA data standards. …
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FDA Medical Product Centers Continue Focus on AI
On March 15, 2024, FDA’s medical product centers – CBER, CDER, and CDRH – along with the Office of Combination Products (OCP) published a paper outlining their key areas of focus for the development and use of artificial intelligence (AI) across the medical product life cycle. The paper, entitled “…
Continue Reading FDA Medical Product Centers Continue Focus on AIFDA Releases Draft Guidance on Electronic Systems, Records, and Signatures in Clinical Investigations
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On March 15, 2023, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (2023 Draft Guidance). The 2023 Draft Guidance revises the draft guidance for industry the Agency issued in June…
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