Drugs

FDA Panel Mulls Cognitive Impairment in Depressive Disorder

FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) 2/3 will discuss whether cognitive impairment in major depressive disorder (MDD) is a suitable target for drug development, and if so, how it should be studied.

Briefing materials released in advance of the meeting note that, historically, CDER’s Division of Psychiatry Products has viewed cognitive dysfunction in MDD as a “pseudo-specific drug target — meaning that this claim would be considered artificially narrow and related to the overall disorder of MDD. Current research supports the concept and subject matter experts have begun to agree that cognitive dysfunction in MDD is a disabling part of MDD which can be considered a distinct problem that to date has not been evaluated in drug trials. While the field is progressing toward consensus on this issue, the purpose of this PDAC meeting is to have the discussion, with experts, in public.”

FDA says that if the panel members agree that cognitive dysfunction in MDD should be studied in drug development programs, then the focus of the meeting will be on how best to measure change in cognitive function in a clinical trial, and what type and how much change is clinically meaningful to patients and clinicians. The agency says it is specifically interested in feedback on acceptable primary efficacy endpoints that can demonstrate clinical relevance for a claim and the trial design to assess change in the endpoints.

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