China’s Center for Drug Evaluation and South Korea’s Ministry of Food and Drug Safety cleared Transcenta Holdings to begin phase III pivotal trials of osemitamab (TST-001) in combination with nivolumab and chemotherapy for first-line treatment of HER2-negative, Claudin 18.2 expressing locally advanced or metastatic gastric or gastroesophageal cancer.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Changzhou Biowin, Getinge, Motive Health, Shineco.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 28 Bio, Bioarctic, Epicentrx, Ichnos, Ips Heart, NS, Transcenta.
The U.S. FDA’s draft guidance for patient-matched guides for orthopedic surgical implants is presumably a much-needed document for makers of these guides, and bench testing may suffice for many such applications. However, the draft states that clinical testing may be required when a manufacturer intends to claim that their guides could reduce surgical times.
Device makers are often cited in U.S. FDA warning letters for making claims not seen in the approved labeling, but the authors of a recent review of artificial intelligence (AI) products cleared by the FDA suggest that FDA documents and marketing materials should disclose the presence of AI in these products. The authors of an article in the Journal of the American Medical Association said that only about 80.6% of the products were represented with accurate statements about the presence of AI, although FDA regulation does not require that marketing materials make such disclosures.
The U.S. FDA’s draft guidance for predetermined change control plans (PCCP) is a groundbreaking document for med-tech regulation, but stakeholders see a few holes in the draft version. One of the issues for device manufacturers is that the guidance seems to exclude any possibility of inclusion of a new intended use or indication for use in a PCCP, while others seek more detail on how this policy can be applied to the device component of a combination product, two elements that may prove complicated to address in the final guidance.
South Korea is making progress towards incorporating digital medical devices into its health care system and facilitating reimbursements, but these efforts may require giving up some entrenched practices. “Digital medical devices” covers a broad range of products, including software and technologies used in therapeutic interventions. They are usually supported by technologies like the Internet of Things (IoT), artificial intelligence (AI), cloud computing, machine learning, sensors and wearables, data analytics and others that can facilitate the shift from traditional health care into the digital world.
Electromedical Products International Inc. (EPI) Alpha-Stim AID technology is finally being made available by the NHS in the U.K. to treat patients with anxiety some two years after the National Institute for Health and Care Excellence (NICE) said there was not enough good-quality evidence to support the case for routine adoption.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Candela, Magstim.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Astellas, Curis, Kazia, Kyverna, Merus, Novavax, OSE, Sihuan.
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