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.
A large epidemiological study published in the July 6, 2020, advance online issue of The Lancet found that most individuals who became infected with SARS-CoV-2 developed antibodies to the virus, confirming that infection usually results in at least a short-term immune response.
A large epidemiological study published in the July 6, 2020, advance online issue of The Lancet found that most individuals who became infected with SARS-CoV-2 developed antibodies to the virus, confirming that infection usually results in at least a short-term immune response.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Aetna, Arrow International, BD, Erba Diagnostics, Eternity Healthcare.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, BD, Centogene, Cochlear, Inmode.
Keeping you up to date on recent developments in cardiology, including: Potassium channel distancing fights stroke; Examining ischemic stroke in patients with COVID-19 vs. those with influenza; COVID-19 infects heart cells in lab dish.
