Drugs

More Patient-Reported Outcome Bias Study Needed: FDA

FDA oncology researchers say that patient-reported outcome (PRO) assessments can contribute important information about the patient experience during treatment with anticancer products and use of such assessments is likely to increase. Writing in JAMA Oncology, the researchers say randomized oncology trials are increasingly open-label, and the accelerated approval pathway is frequently sought for oncology products based on single-arm trials, which can lead to bias in the patient-reported outcomes.

“Rigorous characterization of symptoms and function using PRO measures can complement current trial outcomes, and this information may be incorporated into decision-making by regulators, payers, patients, and families alike,” the researchers say. “It is important to acknowledge that this will take place in a context that has potential for bias. Carefully targeted research that improves our understanding of the existence and magnitude of this bias is important and can inform thoughtful analysis and accurate interpretation of this data.”

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