On October 3, 2017, the Food and Drug Administration announced updates to three final guidance documents, including Form FDA 3926 and its instructions, to simplify Institutional Review Board (IRB) review requirements for physicians seeking to treat an individual patient with an investigational drug under expanded access. The updates allow for a waiver of the requirement for review and approval at a convened IRB meeting if the physician instead obtains concurrence by the IRB chairperson (or a designated IRB member) before treatment use begins.
Additionally, the Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers Guidance has been updated to clarify what adverse event reports that occur during expanded access need to be submitted to FDA, the reason for FDA's review of these events, and the context in which FDA reviews this information. This guidance also provides updated information on the 21st Century Cures Act requirement that companies publicly post their expanded access policies and how patients and health care professionals can determine if a company will provide expanded access to an investigational drug.
Form FDA 3926 and Instructions:
- Form FDA 3926: https://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm504572.pdf
- Instructions for Filling Out Form FDA 3926 - Individual Patient Expanded Access, Investigational New Drug Application (IND): https://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm504574.pdf
- Individual Patient Expanded Access Applications: Form FDA 3926 Guidance: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm432717.pdf
- Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers Guidance: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm351261.pdf
- Waiver of IRB Requirements for Drug and Biological Product Studies Information Sheet: https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126500.pdf
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA's MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).
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