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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
This European Edition of Quick Notes includes guidelines from WHO for pharmaceutical quality control laboratories, UK launch of the Innovative Devices Access Pathway pilot, European Commission (EC) unannounced antitrust inspections at a medical device company and an open letter to the EC about MDR and IVDR. 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
In this edition of Quick Notes, we cover innovative medical devices including a mixed reality system for surgical navigation, robotic system for use in an MRI, a headband EEG and a point-of-care system to detect cardiac disease. Read More
Over the past week, the FDA issued final guidance on conducting clinical trials during major disruptions due to disasters and public health emergencies. Draft guidances were issued on biosimilar and interchangeable biosimilar labeling, demonstrating evidence of effectiveness with one clinical investigation, considerations for prescription drug use-related software, assessing drug manufacturing facilities identified in pending applications and formal meetings between the FDA and pharmaceutical sponsors or applicants. Read More
Upcoming events in the coming weeks include seven 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
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 IRB review of individual patient expanded access submissions, postmarketing requirements and commitments, the Breakthrough Devices Program and the medical device Voluntary Improvement Program. Draft guidances were also issued on clinical and non-clinical studies of weight loss medical devices. Read More