FDA Issues Guidance for IRBs to Help them Review Individual Expanded Access Submissions for COVID-19 Therapies

FDA Issues Guidance for IRBs to Help them Review Individual Expanded Access Submissions for COVID-19 Therapies

COVID-19 ushered in an unprecedented public health crisis. America’s drug and device regulatory, the U.S. Food and Drug Administration (FDA), recently released new guidance for Institutional Review Board (IRB) and clinical investigators to confront individual patient expanded access studies for public health emergencies.

Demands for Expanded Access

The COVID-19 public health crisis has led to an unprecedented increasing in the demand for patient expanded access requests for various investigational therapies and treatments associated with SARS-CoV-2. In addition to existing guidance, the FDA has been actively collaborating with providers, research centers and industry sponsors on individual requests on a case by case basis. In fact, TrialSite News has interfaced with some physicians that have saved lives thanks to these FDA approvals. The agency has been far more responsive that the CDC, for example. 

However, the Agency understands that Institutional Review Boards (IRBs) seek clarity in the context of this COVID-19 pandemic. More specifically, they need more granular insight into the key factors and procedures they should consider when reviewing individual patient expande...

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