Biologics

Reagan-Udall Strategies to Understand Regulated Products

The Reagan-Udall Foundation has published Strategies for Improving Public Understanding of FDA-Regulated Products, providing observations, potential strategies, and illustrative tactics for FDA to consider. A foundation announcement (contains links to the report and a virtual public meeting discussing the findings) says the strategies result from the foundation’s efforts to better understand how consumers and other stakeholders find, consume, and perceive health information, especially as it pertains to FDA-regulated products. “While the strategies are presented for FDA,” the statement says, “many of the challenges addressed are faced across the entire healthcare ecosystem.”

Topline strategies in the report focus on delivering clear, consistent, and timely messages with a focus on pre-bunking (warning about) potential misinformation, the statement says. “Everyone at FDA, not just professional communicators, has a role to play in improving public understanding of FDA and the products it regulates,” 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