Full IRB Review Not Required for Expanded Access Requests, FDA Says
Citing a substantially increased volume of requests for expanded access to investigational drugs to treat COVID-19, the FDA has issued a final guidance that clarifies the conditions under which it will consider sponsor and investigator requests for waivers from full IRB review.
The guidance, which will be in effect only for the duration of the public health emergency, says the agency will grant a waiver if an IRB chairperson or other designated IRB member approves the individual use before treatment begins.
The guidance recommends that IRBs establish procedures for single-member review that focus on assessing the risks and benefits for the patient involved. A new protocol is not necessary for expanded access, the agency says, if the patient’s history and treatment plan provide enough information for the assessment.
To read the guidance, click here: https://bit.ly/30d5Cxy.