Rather than drafting a new guidance, the U.S. FDA’s Center for Drug Evaluation and Research made some clarifying revisions to update its 16-year-old final guidance, “Investigating out-of-specification (OOS) test results for pharmaceutical production.”
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exactech, Jointmedica, Labcorp.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Atamyo, Eli Lilly, Faron, Galera, Gedeon, Inmagene, Junshi, Mitsubishi, Point, Scpharmaceuticals, Sifi, Travere, Valneva, Zenas.
Regulatory harmonization is seen as vital to the development of markets for artificial intelligence (AI) and machine learning (ML), but there is some variation in the terminology used to describe these algorithms. The International Medical Device Regulators Forum (IMDRF) has posted a document that includes some definitions for ML terms such as unsupervised machine learning, a key development if regulations across the globe are to avoid a hopeless state of balkanization.
Among the policies the U.S. FDA’s device center leveraged for testing during the COVID-19 pandemic was the long-standing enforcement discretion lever, which drew less attention than the agency’s use of emergency use authorizations (EUAs). Nonetheless, the Government Accountability Office (GAO) urged the FDA to develop a formal policy for the use of enforcement discretion for pandemic-related tests, including some metrics for when that discretion would come to an end.
Medtronic plc received FDA premarket approval for its Onyx Frontier drug-eluting stent, an update to the company’s Resolute Onyx stent. The Frontier is designed for treatment of patients with coronary artery disease (CAD), a leading cause of death in the U.S. Medtronic expects the stent to receive CE mark shortly.
Valneva SE’s share price plummeted May 16 after the European Commission decided to terminate an advance purchase agreement for millions of doses of its COVID-19 vaccine candidate VLA-2001 because of delays in development. The company’s shares (Paris:VLA) fell more 19% to €9.65 (US$10.07) after it said it would reconsider its financial guidance for 2022.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Checkpoint, Clearmind, Editas, Hansa, Mitsubishi Tanabe, Neurocrine, Polarityte, UCB, Yiling.
The U.S. FDA posted a final guidance for feasibility and early feasibility studies for non-traditional devices for type 2 diabetes, a document that is largely unchanged from the draft. This in the eyes of some stakeholders is precisely the problem as the final guidance retains a set point for rescue medication that some in industry believe is inappropriate for a study that does not seek to establish device effectiveness.
Six weeks ahead of its June 26 PDUFA date, the U.S. FDA has approved a priority NDA for Eli Lilly and Co.’s Mounjaro (tirzepatide), an injectable treatment for adults with type 2 diabetes (T2D). The once-weekly, first-in-class medicine activates both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, which leads to improved blood sugar control. The potential market is massive, as 462 million people across the planet have T2D. The numbers have been growing 1.4% annually as the population ages and grows more obese.
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