Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Canon Medical, Cerapedics, Integra, X-Nav Technologies.
The FDA has approved Xywav (calcium, magnesium, potassium and sodium oxybates; JZP-258), an oxybate product for treating both cataplexy and excessive daytime sleepiness in narcolepsy patients ages 7 and older, from Jazz Pharmaceuticals plc.
Interludes of classical music. Little kids talking in the background. Unmuted mics as panelists multitask. Gurgles of “underwater” sound. Periods of silence as speakers forget to unmute. And then the technical problems – lots of them. Such are the challenges of addressing a virtual FDA advisory committee in the time of COVID-19.
NEW DELHI – Bangalore-based Biocon Ltd. has received the Indian drug regulator's approval for restricted emergency use of its psoriasis biologic, itolizumab, to treat patients with severe cases of COVID-19 in need of ventilator support.
The latest global regulatory news, changes and updates affecting biopharma, including: CDC, FDA, Health Canada, Ono Pharmaceuticals, U.S. Court of Appeals for the Federal Circuit, U.S. Department of Health and Human Services.
The U.S. FDA has put a considerable amount of emphasis on patient perspectives regarding medical devices in recent years, the subject of a recent webinar hosted by the Medical Device Innovation Consortium (MDIC). One of the speakers on the webinar, Carrie Kuehn, of Evidation Health of San Mateo, Calif., said that not only do device makers have a trove of valuable data at their fingertips with patient preference data, but also that the FDA’s message is, “if patients say something, we want to hear about it.”
Hong Kong – Korea’s Ministry of Food and Drug Safety (MFDS) is looking to establish an international common set of guidelines for AI medical devices after its election to the first Chair of Artificial Intelligence Medical Devices (AIMDs) at a meeting of the International Medical Device Regulators Forum (IMDRF).