Expanded Access Guidance On COVID-19 Will Inform US FDA’s Post-Pandemic Policies
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.
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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.
Retraction of Lancet, NEJM studies does not signal doubts about the utility of RWE for evaluating drug efficacy and safety; instead, it highlights importance of transparency, validation and audit trails for real-world datasets, and lack of familiarity with RWE methods among medical journal peer reviewers, experts say.
After Remdesivir's Emergency Use Authorization, US Gov't Must Now Decide How To Distribute Limited Supply
Gilead's antiviral remdesivir will go to hospitalized severe COVID-19 patients per FDA's EUA. Some cities could receive the medicine with days, but it is not clear how the government will dole out the limited supplies. FDA said it had access to non-public data from a key NIH trial during its EUA review.