Tag Archives: OA

Researchers on the Path to a Cure – Spotlight on Dr. Xiaojuan Li

Last year we introduced you to Dr. Xiaojuan Li and her Osteoarthritis (OA) Center of Excellence demonstration research project. The project, “Multi-site Multi-Vendor Cross-validation of Cartilage T1rho and T2 imaging”, was completed by investigators from four sites: the Cleveland Clinic Foundation (CCF) in Ohio; the University of California, San Francisco; the University of Kentucky; and the Montefiore Hospital and Albert Einstein College of Medicine in New York. They worked to quantify biomarker assessments in cartilage images obtained through magnetic resonance imaging (MRI). Continue reading Researchers on the Path to a Cure – Spotlight on Dr. Xiaojuan Li

FDA Osteoarthritis Research

Synvisc-One Injections Recalled

Biotech giant Sanofi Genzyme has initiated a voluntary product recall for one lot of Synvisc-One, a brand of hyaluronic acid. The lot, which was found to contain contamination, has been linked to an unexpected increase in side effects. In an urgent “product hold” letter, doctors, clinics and pharmacies who received syringes from that lot were instructed to immediately stop using the injections on patients until the company can investigate.
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FDA Osteoarthritis Research

Making Progress: Arthritis Foundation and FDA Meet to Make a Difference for Those with OA

With several years gone by since the last drug for osteoarthritis (OA) was approved, the 27 million Americans with OA are ready to hear Yes when it comes to new therapies and diagnostic tests for OA.

Fortunately, this past May, Arthritis Foundation met with Janet Woodcock, the Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) and her colleagues. A representative from the Center for Biologics Evaluation and Research (CBER) also attended the meeting. The goal of the meeting was to discuss how the organizations can work together to design and implement new approaches to clinical trials that will accelerate the improvement of health outcomes for people with OA.

Continue reading Making Progress: Arthritis Foundation and FDA Meet to Make a Difference for Those with OA