Drugs

A ‘New Era of Innovation’ for FDA Public Health Pillars

FDA acting commissioner Kyle Diamantas is commenting on the traditional agency public health pillars that are being rearticulated “in a way that reflects the scientific, technological, and geopolitical reality shaping this new era of innovation as well as the future of public health.” Writing in an FDA Voices online column, Diamantas explains the four public health pillars this way:

ensuring America stays the best place in the world to innovate by providing predictable regulation, rigorous science, timely reviews, and clear expectations;
strengthening America’s health security through the agency’s unique responsibility to anticipate emerging risks, act early, and continuously modernize oversight, including inspections, data-driven risk targeting, and collaboration internally and externally;
helping Americans gain faster access to safe, effective, and more affordable medical products based on scientific rigor and regulatory efficiency; and
continuing to help build a healthier America by helping Americans to avoid the burdens of chronic disease and live longer, healthier lives.

“FDA has always been more than a regulator; it is one of America’s great scientific institutions,” Diamantas concludes. “Institutions that endure for 120 years do so because they never stop learning, improving, and earning the public’s trust…. Though our mission remains unchanged, our responsibility now is to ensure the next century builds on that legacy — empowering our expert career workforce, accelerating scientific discovery, strengthening our nation’s competitiveness, and delivering better health for every American.”

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