FDA announced updates to three final guidances, 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
Guidance Documents:
- Individual Patient Expanded Access Applications: Form FDA 3926 Guidance: https://www.fda.gov/downloads/
drugs/ guidancecomplianceregulatoryin formation/guidances/ucm432717. pdf - Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers Guidance: https://www.fda.gov/downloads/
drugs/ guidancecomplianceregulatoryin formation/guidances/ucm351261. pdf - Waiver of IRB Requirements for Drug and Biological Product Studies Information Sheet: https://www.fda.gov/downloads/
regulatoryinformation/ guidances/ucm126500.pdf
.png)
No hay comentarios:
Publicar un comentario