Biologics

Benefit-Risk is Top CBER Panel Issue: FDA

A new journal article by CBER reviewers that looked at 24 advisory committee meetings held to discuss benefit-risk issues between 2009 and 2021 found that the two most frequently discussed considerations were “uncertainty about assessment of the safety profile” and “uncertainty about assessment of the benefit based on clinical trial data” (16/24 times each).

The reviewers also found that discussions on trial participant demographic diversity took place at many of the panel meetings. “Many of the discussions were regarding the subpopulations that were excluded from some RCTs [randomized clinical trials] of novel products, e.g., children and racial/ethnic minorities,” they wrote. The committees “recognized the importance of factors such as race/ethnicity, sex, and age in clinical trial design so that benefit-risk assessments are more representative of the diversity of the target population.”

The reviewers concluded that a 2021 draft guidance entitled “Benefit-Risk Assessment for New Drug and Biological Products” is a good tool for both FDA and sponsors when planning and preparing for panel meetings. “Identification of key B-R [benefit-risk] factors could be helpful to the FDA in the continuous process of building capacity for regulatory reviews,” they said. “Such capacity building includes, but is not limited to, recruiting experts in areas of emerging technologies and enhancing regulatory science related to B-R assessment methodology, patient inputs, and real-world evidence. This in turn may further facilitate the sound risk-benefit judgments that are at the heart of all FDA regulatory decisions.”

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