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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
Over the past week, the FDA issued final guidances on assessment of tissue containment systems, testing and labeling medical devices for safety in the magnetic resonance environment and draft guidance on quality considerations for topical ophthalmic drug products. Read More
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on what to expect from the FDA in 2024, quality culture and how to use UDI and UDI Data. Read More
Guidance updates, Novo Nordisk complaint against semaglutide compounders tossed, and AdvaMed forms new digital tech division, in this edition of Quick Notes. 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 a proposed rule on laboratory developed tests, final guidance on labeling for dosing of human prescription drugs and biological products and draft guidance on stimulant drug use disorders. Read More
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on what to expect from the FDA in 2024 and how to use UDI and UDI Data. Read More
CBER has issued warning letters to manufacturers for product sterility, failure to seek approval for drug and/or biologic products, inadequate labeling and GMP violations. Read More
As the 118th Congress continues, FDAnews will track important pending legislation 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 quality system considerations and content of premarket submissions for cybersecurity in medical devices. Draft guidances were issued on updating breakpoints in labeling antimicrobial susceptibility test system devices, an electronic submission template for De Novo medical device requests, and developing drugs and biologics for graft-versus-host diseases. Read More
Our coverage includes EMA’s revocation of conditional marketing authorization for Blenrep, FDA approvals for Pfizer’s Bosulif and Viatris/Ocuphire Pharma Ryzumvi, and the FY 2024 priority review voucher fee rate. Read More
Upcoming events in the coming weeks include five FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on calculating sample sizes for verification and validation activities, medical device counterfeiting and what to expect from the FDA in 2024. Read More