Gilead’s Robust Expanded Access For Remdesivir Signals Confidence In Study Enrollment
US FDA has granted about 250 COVID-19 patients expanded access to Gilead’s investigational antiviral; the adaptive trial now underway in US aims for 400 patients.
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In line with Commissioner Hahn’s view that lessons learned during the pandemic will have a lasting impact on FDA policies and procedures, new guidance on IRB review for individual patient access requests will be revised after the public health emergency ends to reflect agency’s implementation experience.
Pivot from individual- to multi-patient protocols for expanded access may help generate data to inform regulatory filings and even payer determinations for Gilead’s potential COVID-19 treatment.
The Canadian government has issued an interim order authorizing the import and sale of two new diagnostic test kits for COVID-19. Other companies making tests for the virus can apply for authorization under the order.