Drugs

Trial Inclusion, Exclusion Workshop Report

An FDA 4/16 public workshop on Evaluating Inclusion and Exclusion Criteria in Clinical Trials addressed the underrepresentation of various populations in clinical trials, how eligibility criteria affect patient access to investigational drugs and enrollment in clinical trials, alternative clinical trial designs that may increase the enrollment of diverse populations, and whether the FDA expanded access program could provide an opportunity to facilitate access to investigational products. A summary of the workshop was released as required by the FDA Reauthorization Act of 2017, which also mandated that a public meeting be held to discuss clinical trial eligibility criteria to inform a guidance on the subject.

The workshop brought together representatives from academia, industry, healthcare delivery, government, and patient advocacy groups to discuss a variety of topics related to the subject, the summary says. “This report is intended only as a summary of the workshop and does not provide guidance or reflect FDA’s current thinking on this subject,” it adds.

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