Drugs

Submitting PRO Data in Cancer Trials Guide

FDA has published a final guidance entitled “Submitting Patient-Reported Outcome Data in Cancer Clinical Trials.” The document provides technical specifications for submitting patient-reported outcome (PRO) data collected in cancer clinical trials to support a marketing application for a medical product in oncology. It defines a PRO as a “type of clinical outcome assessment (COA) used to collect patient experience data” and it is a measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient's health condition without interpretation of the patient’s response by a clinician or anyone else.

FDA says the technical specifications “aim to provide general guidelines for (1) standardized dataset content and structure and (2) recommended tables and figures to facilitate FDA review of the marketing application that the submitted data and analysis outputs are intended to support.” Additionally, it says the recommended tables and figures do not comprise all information needed to support FDA review of a marketing application. “The dataset specifications and specifications for tables and figures are pursuant to discussions with FDA and may vary by clinical drug development program and clinical trial therein,” it says.

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