Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter International, Diazyme, Infervision, Therapixel.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allergy, Anaptysbio, Assembly, Astrazeneca, Chemocentryx, Crinetics, Fate, Fujifilm, Immodulon, Leo, Merck, Mylan, Osmotica.
Plymouth, Minn.-based Nonin Medical Inc. gained a U.S. FDA 510(k) clearance for its Co-Pilot wireless hand-held multiparameter system (H500). The system is expected to be used by first responders to evaluate various oxygenation and respiratory-related parameters in patients after incidents such as cardiac arrest, traumatic injury, carbon monoxide or smoke inhalation.
The U.S. FDA’s priorities for testing for the SARS-CoV-2 virus have shifted as circumstances have changed, and the agency is putting more emphasis into testing of pooled samples. Toby Lowe, the associate director of the Office of In Vitro Diagnostics and Radiological Health (OIR), said on the July 8 diagnostic town hall that the agency wants to encourage test developers to work on their existing EUAs for pooled sampling.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Balt, Nonin Medical, Saladax Biomedical, Urocam.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aclaris, Asieris, Astrazeneca, Biogen, Concert, Cormedix, Croma-Pharma, Eisai, Merck, Talaris.
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