Institutional Review Board Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency; Guidance for Institutional Review Boards and Clinical Investigators; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency." To facilitate patient access to investigational drugs for treating COVID-19, FDA is issuing this guidance to provide recommendations regarding the key factors and procedures IRBs should consider when reviewing requests-- including when such reviews are conducted by a single-member of an IRB--for individual patient expanded access. Given the public health emergency presented by COVID-19, this guidance is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices.