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Focus on Regulation

Tag Archives: IRB

FDA Simplifies and Clarifies Expanded Access Program

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program.  Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment with an investigational product when there is no therapeutic alternative.  In particular, FDA made three announcements: FDA has decided that physicians requesting individual patient

“Institutional Review Board (IRB) Written Procedures” Draft Guidance and NIH’s “Single IRB Policy” Offer Food for Thought to IRBs Charged with Oversight of Human Subjects Research

Last week, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS) issued joint draft guidance on responsibilities for preparing and maintaining written policies and procedures for Institutional Review Boards (IRBs). The agencies, both responsible for issuing and enforcing federal regulations designed to protect human subjects in research, have been working together to harmonize federal regulatory requirements and guidance in this area. The draft guidance entitled “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs” (the Draft Guidance) is designed to assist IRBs and institutions responsible for the review and oversight of human research protections under both FDA (21 CFR Parts 50 and 56) and HHS regulations (45 CFR Part 46).

HHS Seeks Comments on Transfer of IRB Oversight Draft Guidances

HHS’ Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) have simultaneously released notices seeking comments on draft guidance documents regarding the transfer of previously approved research projects to another Institutional Review Board (IRB) or research institution.  These guidances were released as part of a joint effort between the FDA and