Drugs

Concerns Voiced on IRB Guidance

Public Responsibility in Medicine and Research (PRIM&R) says it agrees with the need for additional guidance on institutional review boards (IRBs), but has concerns about a guidance with an IRB written procedures checklist issued by FDA and the HHS Office for Human Research Protections. The group cautions that “excessive attention to documentation” will lead to unnecessary expenditure of time and effort by both the IRB and investigators at the expense of more meaningful efforts to promote human subject protections by educating reviewers and enhancing reviews. “If satisfying the requirements of the checklist becomes a compliance goal in and of itself,” the letter says, “more valuable opportunities to promote protections may be lost. It is important for the checklist to contribute to improved understanding of regulatory requirements and how these can be translated into practice.”

In its letter, Bristol-Myers Squibbs suggests that the guidance could be strengthened through clarification and differentiation of legal obligations from recommended activities, consideration of sponsors and audits not included in the document, and some additional items.

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