The U.S. Senate on Dec. 16 passed the FDA Modernization Act 3.0 (S.355) by unanimous consent, sending legislation to the House that would require the FDA to update its regulations to reflect changes Congress enacted in 2022. The bill instructs HHS, acting through the FDA commissioner, to publish an interim final rule no later than…
Digital ready, regulatory waiting: The clinical trial pathology paradox
While diagnostic pathologists can review scanned slides remotely with AI assistance and instant global collaboration, much of the clinical trial pathology world still ships physical glass slides between labs, dealing with FedEx delays and proprietary file formats. “For exploratory assays, yes, it’s exploding. Everyone’s enjoying artificial intelligence and machine learning for various aspects, but there’s…