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As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
In this edition of Quick Notes, we look at 510(k) clearances for an at-home intravaginal insemination kit, a fingertip blood collection device, first surgical navigation system for total ankle arthroplasty, a rapid anthrax toxin test, an AI-based chest x-ray triage solution, and an acute kidney injury biomarker test for pediatric use. Read More
Over the past week, the FDA issued draft guidance on advanced manufacturing technologies designation program and announced the establishment of a new advisory committee on genetic metabolic diseases. Read More
This edition of Quick Notes looks across the pond at Europe’s new critical medicines list, reference labs for high-risk IVDs, guidelines for adverse reaction follow-ups and a tweaked website. Read More
Upcoming events in the coming weeks and months include two FDA advisory committee meetings; and MAGI 2024: The Clinical Research Conference in New Orleans. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, 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 verification systems for certain prescription drugs under the Drug Supply Chain Security Act and draft guidances on the interim policy on compounding using bulk drug substances under Section 503A and 503B of the FD&C Act. Read More
In this edition of Quick Notes, we review recent FDA drug approvals of Jaypirca for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma, Ogsiveo for desmoid tumors who require systemic treatment, Fabhalta an oral monotherapy for the treatment of PNH and a priority review voucher award for Genzyme. Read More
Upcoming events in the coming weeks and months include two FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on overcoming common clinical trial challenges, supplier quality agreements and FDA inspections. Read More
In this edition of Quick Notes, we look at expanded clearance for a smart watch, a retinal camera with designs on uncovering health problems, new software to better track neurological disease and a way to increase radiologists’ efficiency by enabling remote review of MRI scans. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More