Drugs

Address Heart Failure Patient-Reported Outcome Issues

Researchers from FDA and several hospitals say there is increasing interest in using patient-reported outcomes (PROs) as endpoints in heart failure trials and regulatory bodies have shown a willingness to consider heart failure drugs and devices for approval based on improvement in PROs. Writing in the journal Circulation, the researchers say several issues need to be resolved before the use of PROs can be successfully implemented:

there is no consensus on the optimal tool to measure PROs or the appropriate timing and frequency of PRO assessments in heart failure tests;
among the two most commonly used tools, there is no universal definition of what constitutes a minimal clinically important difference;
the ideal statistical method to compare changes in PROs in intervention and control groups is unclear; and
some trials have shown no benefit in PROs despite improving clinical outcomes that would be expected to affect quality of life and more discussion is needed on how to interpret this finding and the discordant benefit needs.

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