Drugs

FDA Seeking COA Compendium Comments

FDA is seeking public comment on its pilot Clinical Assessment Outcome (COA) Compendium, which the agency says is part of efforts to foster patient-focused drug development. “The COA Compendium is intended to facilitate communication and to provide clarity and transparency to drug developers and the research community by collating and summarizing clinical outcome assessment information for many different diseases and conditions into a single resource,” the compendium Web site says.

The site defines the COA Compendium as a table that (1) describes how certain clinical outcome assessments have been used in clinical trials to measure the patient’s experience (such as disease-related symptoms) and to support labeling claims; (2) identifies clinical outcome assessments that have been qualified for potential use in multiple drug development programs under the COA type of the CDER Drug Development Tool Qualification Program; and (3) recognizes ongoing qualification projects to encourage community collaboration in developing clinical outcome assessments for unmet measurement needs.

A Federal Register notice says the pilot was created to help the agency determine the utility of the COA Compendium, develop future iterations of it, and identify best methods for conveying COA Compendium information on FDA’s Web site.

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