The rescission order directing the U.S. FDA to abandon regulation of lab-developed tests is scarcely three weeks in the past, but two senior managers at the FDA are pushing back in an editorial appearing in the New England Journal of Medicine. The FDA’s Jeff Shuren and Tim Stenzel wrote that there is “a need for a common legislative framework” to ensure clinical tests are accurate and reliable, which implicitly concedes that the statute does not authorize the agency to regulate lab-developed tests.
Keeping you up to date on recent developments in diagnostics, including: Deep learning aid for diagnosing TB in HIV patients; Self-collected swabs vs. health care worker collected for COVID-19 testing; SCAD vs. plaques in heart attacks; Diagnosing neuroblastoma in children.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Exsomed, Glaxosmithkline, Innoviva, Izi Medical, Verily.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avenu Medical, Axonics, Hyperfine, Medifiber, Reshape Lifesciences.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Genmab, GSK, Halozyme, Sarepta, Terns, Zai Lab.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ADC, Astrazeneca, Axon, Brink, Clinuvel, Cmab, Cobra, Combigene, Fresenius Kabi, Gain, Generate, Havn, Immunomic, Immunoprecise, Kempharm, Know, KVK-Tech, Laekna, Ligand, Nabriva, Orion, Rockwell, Sumitomo Dainippon, Totient.
Vaccine hesitancy could slow the development of herd immunity for COVID-19 in the U.S., but there could be other ways to help reach it. Testifying at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing Sept. 9, Surgeon General Jerome Adams said the numbers needed for herd immunity vary from expert to expert, but it ranges from 60% to 80% of the population.
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