Zimmer Biomet Holdings Inc.’s Rosa robotics surgical assistant snapped up its fourth application with the U.S. FDA’s 510(k) clearance for use in shoulder replacement surgery. Over the past five years, the system has built a portfolio that includes partial and total knee replacement and total hip replacement.
Clearmind Medicine Inc. has received approval from Israel’s Ministry of Health to initiate a phase I/IIa trial of CMND-100 oral capsules for alcohol use disorder (AUD). The multinational trial in healthy volunteers and AUD subjects will be conducted in Israel and the U.S.
As chronic drug shortages continue in the U.S., yet another congressional investigation into the problem has been launched. But instead of a wholistic search for the root causes, this one, launched by the Democratic members of the House Oversight Committee, focuses on three drug companies – Pfizer Inc., Sandoz Inc. U.S. and Teva Pharmaceuticals USA Inc.
Instead of inter partes review (IPR) being a streamlined alternative to costly patent litigation as intended, a precedential decision by the U.S. Circuit Court of Appeals for the Federal Circuit could make appeals of IPR decisions, regardless of their merits, another way to delay competition.
South Korea’s MFDS gave regulatory clearance to SK Inc. C&C’s artificial intelligence (AI) solution to diagnose cerebral infarction called Medical Insight+ Brain Infarct on Feb. 22, as a class III device.
The U.S. FDA’s December 2023 draft guidance for the use of real-world evidence (RWE) for medical devices drew comment from across the spectrum of stakeholders, but industry is demonstrably wary of the draft on several points. The Medical Device Manufacturers Association (MDMA) offered several pointed criticisms, including that the draft seems to suggest that a fit-for-purpose study might be nearly indistinguishable from a conventional clinical trial, which MDMA said violates the least burdensome principle.
A China-based manufacturer of active pharmaceutical ingredients (API) suspended producing API for the U.S. market following an FDA inspection that found “significant deviations” from good manufacturing practices at the facility.
After nearly a decade and a half of service at the U.S. FDA, Bill Maisel will retire from the agency, taking with him a wealth of experience as both a physician and a regulator. The agency said Owen Faris, also a long-time member of the FDA staff, will take Maisel’s place as the director of the Office of Product Evaluation and Quality (OPEQ), but this is a temporary stint for Faris as the agency will conduct a search for Maisel’s replacement.
Third-party testing of medical devices is an established practice, but some testing labs are more reliable than others. The U.S. FDA has warned device manufacturers that some of these labs are turning out falsified data in connection with such testing, calling out labs located in China and India as unusually suspect sources of testing data.
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.
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