FDA announces project to advance diagnostics, approves new intubation/ventilation drug

Jun 18, 2020 - 03:23 PM
FDA-guidance

The Food and Drug Administration today announced a public-private partnership to advance COVID-19 diagnostics.

“While there are current studies of viral diagnostic and antibody tests using traditional assessment methods, the Diagnostics Evidence Accelerator will allow the community to analyze both diagnostic and clinical data in real time, which has the potential to contribute to the scientific evaluation of diagnostic tools and medical interventions for COVID-19,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D.

The project is a companion to a Therapeutic Evidence Accelerator launched by the Udall Foundation for the FDA and Friends of Cancer Research in April, which brings together experts in health data aggregation and analytics to inform the collective COVID-19 response.

In other COVID-19 news this week, FDA approved a new drug to facilitate tracheal intubation and muscle relaxation during surgery or mechanical ventilation; and issued warning letters to three companies for marketing unauthorized test kits directly to consumers for at-home use.

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