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In this edition of Quick Notes, we review recent FDA drug approvals of Zepbound for weight loss, Fruzaqla for colorectal cancer, Cosentyx for hidradenitis suppurativa, Keytruda for biliary cancer, and Stelara biosimilar Wezlana for several inflammatory diseases. 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
In this edition of Quick Notes we tackle regulatory activity across the pond in Britain and the EU with stories on increased EMA fees, electronic product information for medicines, an updated service to help pharmaceutical companies and repurposing of a drug to help prevent breast cancer. Read More
Over the past week, the FDA issued final guidance on real-time oncology review and cosmetic product facility registration and product listing. Read More
Upcoming events in the coming weeks and months include two FDA advisory committee meetings, MAGI 2024: The Clinical Research Conference as well as webinars on choosing the right IRB review partner, medical device cybersecurity and overcoming common clinical trial challenges. Read More
This edition of Quick Notes highlights the outcome of an adcomm on a device to eliminate cancer cells from blood collected during surgery, the FDA’s acceptance of a medical device cybersecurity consensus standard, and two post-market studies of cardiac device efficacy.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 guidances on enforcement for certain supplements for PMA or HDE submissions and clinical electronic thermometers enforcement policy. The agency is also proposing to exempt certain clinical electronic thermometers without telethermography from premarket notification requirements. Read More
In this edition of Quick Notes, we cover drug approvals for Roche’s Vabysmo for macular edema, Servier’s Tibsovo for treatment of IDH1, Coherus’ and Shanghai Junshi Biosciences’ Loqtorzi for nasopharyngeal cancer, Santhera Pharmaceuticals’ Agamree for treatment of Duchenne muscular dystrophy (DMD) and Eli Lilly’s Omvoh for treatment of ulcerative colitis. Read More
Upcoming events in the coming weeks include three FDA advisory committee meetings as well as the 18th Annual Inspections vSummit from FDAnews, a WCG company, and webinars on how to use UDI and UDI Data, the importance of selecting the right partner for independent expert committees, choosing the right IRB review partner and medical device cybersecurity. Read More
In this edition of Quick Notes, we cover medical device clearances for GE HealthCare’s Allia IGS Pulse for cardiac imaging, Ventric Health’s Vivio system for heart failure diagnosis, the Ori by Masimo to analyze oxygen saturation and the TriLEAP anatomic plating system, a procedure-specific system designed for orthopedic clinicians. 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