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FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company | JD Supra
JD Supra· 24 hours agoOn May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences ...
FDA’s Final Rule on IVDs: a stop gap en route to the VALID Act?
Medical Device Network via Yahoo Finance· 6 days agoAfter years of back and forth with industry, the FDA has made explicit that IVDs are medical devices...
FDA accepts Sanofi’s Sarclisa sBLA for priority review
Pharmaceutical Technology via Yahoo Finance· 7 days agoTo streamline the process of bringing new medicines to patients, the companies will combine their...
Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests | JD Supra
JD Supra· 24 hours agoAs detailed in our prior analysis (here), the final rule amended the FDA’s existing regulations to make explicit the agency’s interpretation that LDTs are “devices” under ...
Psychoactive drugs are having a moment: The FDA will soon weigh in
Medical Xpress· 17 hours agoLori Tipton is among the growing number of people who say that MDMA, also known as ecstasy, saved...
FDA finalizes guidance on “Remanufacturing” vs “Servicing” | JD Supra
JD Supra· 5 days agoIn contrast, servicing is “ the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it ...
FDA urged to relax decades-old tissue donation restrictions for gay and bisexual men
Medical Xpress· 6 days agoAdvocates, lawmakers, and groups focused on removing barriers to cornea donations, in particular,...
FDA Roundup: May 31, 2024
The Pilot News· 4 days agoToday, the FDA approved mRESVIA (Respiratory Syncytial Virus Vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV ...
Optum joins FDA, manufacturer in recalling infusion pumps that killed one patient
Medical Xpress· 4 days agoFood and Drug Administration in recalling an infusion pump system that has killed at least one...
Canary Medical’s Smart Spine Lumbar Cartridge Granted FDA “Breakthrough Device” Designation
Digital Journal· 6 days agoCanary Medical, a medical data company focused on the development and commercialization of its patented implantable sensor technology and complementary data and analytics ecosystem, today announced ...
