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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
Shouldering the cost of FY25 federal employee pay increases may cause the FDA’s Office of Regulatory Affairs (ORA) to reduce the number of inspections it can conduct, said the office’s Associate Commissioner for Regulatory Affairs Michael Rogers during an Alliance for a Stronger FDA webinar Wednesday. Read More
The Apple Watch’s atrial fibrillation (AFib) history feature is now qualified as the first digital health technology under the FDA’s Medical Device Development Tools (MDDT). Read More
SonarMed Airway monitors and sensors saw two separate Class I recalls for a restricted inner diameter in the airway and software that failed to detect the partial obstruction, while BioMérieux saw a Class I recall for an antibiotic sensitivity test kit that could produce inaccurate results. 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
The FDA is soliciting written feedback as well as presenters to speak on its use of and processes for its advisory committee during a virtual listening session scheduled for June 13. Read More
In the wake of Congress repeatedly trying and failing to pass the bipartisan Verifying Accurate, Leading-edge IVCT (In-Vitro Clinical Test) Development (VALID) Act, the FDA today announced its final rule declaring that in vitro diagnostic products (IVD) manufactured in a laboratory are now considered medical devices, and thus under the regulation of the FDA. Read More