FDA Policy/General

Heart Questionnaire Qualified for Device Developers

FDA has qualified the Minnesota Living with Heart Failure Questionnaire from the University of Minnesota as part of its Medical Device Development Tools program. It aims to reduce regulatory burden by qualifying tools that can aid in developing and evaluating devices. Qualified tools can be used by industry to support submissions, “which could reduce time and resources involved in product development,” an agency notice says.

The questionnaire features 21 self-administered questions designed to measure the adverse effects of heart failure on patients’ lives. “The patient receives a brief set of instructions, and then uses a scale from zero to five to indicate how much each dimension of heart failure has affected their life over the previous four weeks,” the agency says. “The questionnaire asks patients to rate the following dimensions of quality of life: (1) physical symptoms and signs of heart failure, (2) common physical/social functions, (3) psychosocial and cognitive function, and (4) overall adverse impact on quality of life.”

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