FDA Policy/General

Two Proposed Rules Modify Certain IRB Oversight

Federal Register proposed rules: FDA is issuing two proposed rules that modify certain research requirements regarding approval/oversight by institutional review boards (IRBs). One proposed rule would replace current requirements for FDA-regulated cooperative research with new requirements that would require any institution located in the U.S. participating in such research to rely on review and approval by a single IRB for that portion of the research that is conducted in the U.S., with some exceptions. FDA is also proposing an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution. FDA is proposing these revisions to streamline the IRB review process and decrease administrative burdens and inefficiencies for investigators and IRBs without compromising human subject protections. This proposed rule would harmonize FDA’s requirements for cooperative research and IRB records, to the extent practicable and consistent with statutory provisions, with the “Federal Policy for the Protection of Human Subjects” (revised Common Rule) and is mandated by the 21st Century Cures Act (Cures Act)

The other proposed rule would amend FDA’s regulations to modernize, simplify, and enhance the current system for oversight of FDA-regulated human subject research. It would harmonize certain sections of FDA’s regulations on human subject protection and IRBs, to the extent practicable and consistent with other statutory provisions, such as the Common Rule and CURES Act. The proposal is also intended to reduce the regulatory burden on IRBs, sponsors, and investigators.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome