The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug (IND) application. The guidance now includes new frequently asked questions about how expanded access should be implemented given new regulatory access and statutory requirements through the 21st Century Cures Act (Cures Act) and FDA Reauthorization Act of 2017 (FDARA).
While the guidance remains largely the same from 2017, FDA added new recommendations for Institutional Review Board (IRB) review, informed consent and new requirements in Cures Act and FDARA to publicly share sponsor policies on evaluating and responding to expanded access requests, the agency said.
“The manufacturer or distributor is required to include their contact information, procedures for submission of expanded access requests, general criteria for evaluation and response, the anticipated time frame for acknowledgement of such requests, and a hyperlink or other reference to the record in ClinicalTrials.gov that contains information about availability of the drug under expanded access,” FDA wrote…
