Guidance Mar 19, 2021 Emergency Use of a Test Article in Life-Threatening Circumstances This guidance describes the circumstances regarding Expanded Access Emergency Use ( Emergency Use ) of an investigational product (drug, biologic , or device) and the procedures to be followed before or immediately following the emergency use of an...
Guidance Nov 2, 2020 FDA guidance - General, Drug and Biologicals, Medical Devices, and FDA operations The term “ test article ” is found in the FDA regulations on Protection of Human Subjects ( 21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals , and gene therapy, and genetically derived products that meet the...
Templates May 11, 2020 Humanitarian Use Device (HUD) Informed Consent Template This template should be used when submitting the Humanitarian Use Device (HUD) informed consent documents. The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the...
Guidance May 11, 2020 Humanitarian Use Device Requirements for U-M Physicians & Investigators The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals...
Policies Nov 21, 2019 University of Michigan Medical School Policy on Requirement to Use MICHR MIAP Services This Office of Research policy addresses MICHR IND/IDE Investigator Assistance Program (MIAP) support and oversight for Medical School personnel and university personnel using IRBMED who serve or seek to serve as FDA-recognized Sponsors or Sponsor-... Tags: MICHR
Guidance Jun 1, 2018 Emergency Research (Planned and Approved) with Exception from Informed Consent The Food and Drug Administration’s regulation at 21 CFR 50.24 allows a narrow exception to the requirement to prospectively obtain and document informed consent from research subjects. According to the regulation, IRBs may approve certain emergency...
Guidance May 7, 2018 FDA Expanded Access Program at the University of Michigan For assistance in obtaining approval to use an Expanded Access investigational product, contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing UM-Expanded-Access-Request@med.umich.edu The FDA Expanded Access program allows a...
Policies May 26, 2017 Statement of Practice: Sections 15 and 16 of IRB Application Click here for PDF version. What Agents/Articles must be listed in Sections 15 and 16 of the IRBMED eResearch application? Note : This document outlines IRBMED recommendations for completing the eResearch application. Other committees may make...
Templates Mar 29, 2017 FDA Expanded Access Informed Consent Template This template should be used when creating an FDA Expanded Access informed consent document. This template is designed for use in all Expanded Access uses, which include both Compassionate Use and Emergency Use. For more information on specific...
Guidance Mar 8, 2013 Electronic Records and Electronic Signatures (21 CFR Part 11) The regulations in 21 CFR Part 11 set forth the criteria under which FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper...
Guidance Apr 17, 2012 Federal Regulations - ARCHIVED 04/23/2021: This page has been archived. IRBMED Guidance pages throughout Research A-Z link to relevant federal websites Regulations enforced by the Food and Drug Administration (FDA) 21 CFR 50 -- Protection of Human Subjects 21 CFR 56 --...
Guidance Jul 10, 2020 eResearch Cross-Reference Table These documents provide direction on consistency in application changes for the most common changes to the eResearch (IRB) application and the supporting materials. The "Table" indicates correspondences between all eResearch sections for certain...
