Drugs

Research Mulls Approach to Qualify Patient-reported Measures

New research published in the 10/25 online PLOS One journal and supported by CDRH’s Division of Biostatistics outlines an approach that could lead to more patient-reported outcome measures (PROM) being included in drug and device labeling. The researchers say the “PROM has to be valid, reliable and able to detect a change if the targeted disease status changes. One approach to assess the quality of a PROM is to investigate the association between the PROM and an objective clinical endpoint measuring the status of a disease/condition. However, methods assessing the association between continuous and discrete variables are limited, especially for correlated measurements.”

The online paper proposes a method to assess such an association with any type of samples with or without correlation. “The method involves estimating the probability revealing the status of a subject’s disease/condition (called truth thereafter) through the subject’s reported outcomes,” the researchers write. “The probability is a conditional probability revealing truth given the relative location of the subject’s objective outcome compared to the subject-specific latent threshold in the objective endpoint. A consistent estimator for the probability is derived. The operating characteristics of the consistent estimator are illustrated using simulation.”

To view the online article, click here.

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