Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aethlon, Athletic Heart, BD, Camtech Health, Diacarta, Dynocardia, Hyperfine, Route 92, Theranica.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Sira Medical, Zylox-Tonbridge.
After more than a decade of industry pleading for guidance on Orange Book patent listings, the U.S. FDA is finally planning on answering that request this year. If the guidance that’s produced reflects the FTC’s position that device patents can’t be listed for combination products, it could overturn years of accepted practice and possibly hinder the development of new, more advanced drug administration technologies.
Unless there’s a last-minute meeting of the minds, it looks like any extension of the World Trade Organization’s (WTO) five-year intellectual property waiver for COVID-19 vaccines will be shelved, at least for now.
The U.S. FDA’s device center has been prodding industry for some time to develop a culture of quality regarding the manufacture of medical devices, an emphasis that has resulted in the development of several programs. While the recent harmonization of the FDA’s device quality system regulation with an international standard might seem oblique to this culture of quality consideration, the FDA’s Keisha Thomas advised industry that the overhaul of the Quality System Regulation (QSR) is seen inside the agency as part and parcel of that quality push, a statement that seems to suggest that the FDA’s expectations regarding device manufacturing will be more stringent going forward.
Better Therapeutics Inc.’s prescription digital therapeutic (PDT) received U.S. FDA breakthrough device designation for metabolic dysfunction-associated steatohepatitis (MASH), an advanced form of fatty liver disease that increases the risk of cirrhosis, liver failure and liver cancer but has few good treatments available.
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