Integra LifeSciences reports FDA warning letter related to quality system issues
In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the ...
JD Supra4d
FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...
Nature11y
Quality by design for biopharmaceuticals
Following in the footsteps of the other review programs at the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science, the Office of Biotechnology Products (OBP) is currently in ...
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FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions
FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management ...
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Integra LifeSciences reports FDA warning letter related to quality system issues
In the 2024 Form 483s, the FDA deemed certain of the company ... a systematic and holistic approach to improving its quality management system across its manufacturing and supply network.