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This week, the FDA announced a Metabolic Drugs Advisory Committee meeting and a listening session on advisory committees. Draft guidances were published on content and format of NDA and ANDA labeling statements, use of human- and animal-derived materials in the manufacture of CGT and TEMP products, safety testing of human allogeneic cells. Read More
This edition of Quick Notes reviews the FDA’s approval of Medtronic’s closed-loop rechargeable spinal cord stimulator, Abbott’s below the knee Everolimus Eluting Resorbable Scaffold System, an integrated continuous glucose monitor, and clearance of AEYE Health’s AI that diagnoses referable diabetic retinopathy. Read More
This edition of Quick Notes provides an overview of four recently released draft guidances on the manufacture of cell-based products and on the FDA’s enforcement policy regarding test manufacturers’ offering of certain unapproved tests during a future declared emergency or in the absence of such a declaration. 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
This week, the FDA announced a Medical Devices Advisory Committee meeting, availability of a report on postmarketing performance of drug firms, revised draft guidance on biologic promotional labeling and advertising, three draft guidances on cancer clinical trial eligibility criteria, and a request for comments on promoting effective drug development. Read More
In this edition of Quick Notes, the FDA finally OKs a 40-year-old European mainstay antibiotic for uncomplicated UTIs, an immunotherapy for bladder cancer, a generic form of Narcan nasal spray, and a pediatric version of Lutahera — the first-ever radioligand approved for use in children. 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
This edition of Quick Notes looks at FDA clearances and classifications for devices involving cranial implants, Parkinson’s Disease symptoms, at-home blood sampling and robotic microsurgery. 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
A consent decree of permanent injunction against Philips Respironics restricting the production and sale of new CPAP and BiPAP machines and mechanical ventilators at three U.S. facilities has been entered by the U.S. District Court for the Western District of Pennsylvania. Read More