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Federal Register notice: FDA announces a 12/13 virtual public workshop entitled Patient-Focused Drug Development: Workshop to Disc...[ Price : $8.95]
Boston Scientific recalls (Class 1) its POLARx and POLARx FIT Cryoablation Balloon Catheters because of atrio-esophageal fistula r...[ Price : $8.95]
LivaNova says its aura6000 obstructive sleep apnea treatment met the safety and efficacy endpoints in the OSPREY trial in adults.[ Price : $8.95]
GAO healthcare director Mary Denigan-Macauley says FDA needs a plan and a strategy for recruiting and retaining new facility inspe...[ Price : $8.95]
FDA clears a GE HealthCare 510(k) for its Signa Magnus, a 3.0T high-performance, head-only MRI scanner.[ Price : $8.95]
FDA warns Mechanicsville, VA-based American Contract Systems about Quality System Regulation violations in its manufacturing of st...[ Price : $8.95]
FDA warns Chinas Zhejiang Qimei Cosmetic Co. about CGMP violations in its manufacturing of OTC drugs.[ Price : $8.95]
FDA accepts for review an Abeona Therapeutics BLA resubmission for prademagene zamikeracel (pz-cel), a gene therapy for patients w...