Gilead's Expanded Access Shift Offers New Data Collection Opportunities For Remdesivir
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.
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High-profile programs, such as convalescent plasma, also created public confusion about role of preapproval access and highlighted the importance of prospectively planning for reliable data collection, experts said at the DIA global annual meeting.
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.
Spain has suffered more than most from COVID-19 but the life sciences sector is exploring a variety of ways to tackle the coronavirus pandemic.