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Lapses in digital security, missed report deadlines, and a complete lack of quality oversight earned manufacturers some notable 483s. And here’s a first: How about getting written up for being too clean? Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
In this edition of Quick Notes, we hop across the pond to check out the EMA’s new regulatory fees structure, its updated submissions communication portal, and the sixth update of its guideline on the clinical evaluation of anticancer medicinal products. Read More
Over the past week, the FDA issued final guidance on revising ANDA labeling, draft guidances on metallic coatings and/or calcium phosphate coatings on orthopedic devices and conducting remote regulatory assessments. The agency also announced a meeting of the circulatory system devices panel of the medical devices advisory committee and posted best practices for FDA staff in postmarketing safety surveillance. Read More
This edition of Quick Notes looks at the FDA approving devices and systems that detect and/or offer treatment for potential skin cancer, Alzheimer’s, lung fibrosis and diabetic neuropathy. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Over the past week, the FDA issued final guidance on drug security at the package level and announced a meeting of the medical imaging drugs advisory committee. Read More
This edition of Quick Notes includes coverage of a cloth vest/halter that continuously monitors blood pressure, a Mayo Clinic deal on a newly cleared breast tumor 3D modeling device, and Medtronic clearances for a deep brain stimulation system for movement disorders and an insulin delivery system. Read More
Over the past week, the FDA issued a final guidance viral safety evaluation of biotechnology product derived from human or animal cells and draft guidance on sterility information in 510(k) premarket notifications and requests for reconsideration of division level under GDUFA. Read More
This edition of Quick Notes looks at recent FDA medical device clearances and designations for EndoSound, EndoQuest Robotics, Perfuze, AnX Robotics, CGBio. Read More