The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warning letter to company promoting test kits.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hearthero, Novocure.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angiocrine, Bioxcel, Gyroscope, Inventiva, Sebela, Sorrento, Surface.
The U.S. FDA final guidance for microneedling devices is a product-specific guidance, but it raises questions about the agency’s perspective on how a manufacturer’s intended use is inferred. Despite concerns voiced by industry, the microneedling devices final guidance retains a feature of the draft that allows the agency to infer intended use from the manufacturer’s “expressions,” a provision that raises yet again the long-standing commercial speech problem.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDC updates vaccine guidance; Russia launches doctor-driven shortage reporting service.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocartis, Icotec, Materialise, Medcad.
Now that the FDA has granted emergency use authorization to Eli Lilly and Co.’s bamlanivimab, the company plans to manufacture up to 1 million doses of the therapy by year-end with worldwide distribution to mild to moderate COVID-19 patients ages 12 and older in early 2021.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Betterlife, Clinigen, Emmaus, Forma, Immune-Onc, Lilly, Oryzon, Praxis, Rafael, Supernus.
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