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 expanded access submissions. These submissions can even consist of one single member of the IRB seeking to comply with 21 CFR Part 56.
Hence, the Agency offers recommendations in association with the key factors and procedures for IRBs to consider when faced with the need to review expanded access submissions in association with individual patient access to investigational drugs—all in response to the SARS-CoV-2 based Pandemic.
Call to Action: Follow the link to review the FDA recommendations.