Many of the developers of in vitro diagnostic tests will seek to convert their emergency use authorizations (EUAs) to conventional premarket filings, and Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said a draft guidance for this conversion is in process. However, Stenzel said he could not predict when that draft might emerge, given that the agency is still scrambling to keep up with both EUA and conventional applications.
Lucira Health Inc. has secured U.S. FDA emergency use authorization for the first prescription molecular diagnostic test for COVID-19 that can be performed from start to finish in the convenience of one’s home. The single-use, COVID-19 All-in-One Test Kit employs a simple ‘swab, stir and detect’ design that yields results within 30 minutes – enabling individuals who expect they have the virus to get results while isolating at home.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HQO recommends home UVB therapy; Health Canada announces testing advisory panel.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Path, Invent Medical, Lucira Health.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3shape, Accuray, Align Technology, Baylis Medical, Bellaseno, Cipla, Collective Medical, DHL Supply Chain, Fraunhofer Institute for Cell Therapy and Immunology Izi, Foundation Medicine, Health Care Service, Healint, Innoture, International Medical Solutions, Japan Lifeline, Multi-G, Nexstim, Northpond Ventures, Nucleix, Olympus, Philips, Premier, Prescient Surgical, Summerbio, Summit Biolabs, Sybridge Technologies, Teledyne, Twinstrand Biosciences, Va-Q-tec, Vital AI, X-Cell Tool and Mold.
With the FDA’s required safety milestone notched in their phase III study of COVID-19 vaccine candidate BNT-162b2, Pfizer Inc. and Biontech SE said they will request emergency use authorization “within days.”
Concerns about biopharma executives profiting from stock sales aligned with releases of promising COVID-19 vaccine results could result in Congress requiring a cooling-off period for executives’ 10b5-1 plans that provide a safe harbor to insider trading.
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