FDA Policy/General

Hahn’s 1st Address Targets Data Modernization as Priority

FDA commissioner Stephen Hahn says “unleashing the power of data” will be a key objective while he is at the helm. In his first all hands address to FDA employees 1/31, Hahn said that attaining more and better data to support the work the agency is doing will be a top priority. He said data modernization and integration continue to be a priority, but FDA also eeds to be “more proactive in gathering data, and to be more creative and thorough in our analysis of it. By harnessing this power, we can improve our regulatory decision-making and more effectively connect today’s groundbreaking scientific discoveries with the rapid development and approval of new products.”

Presumably addressing recent criticism that FDA may be risking its gold standard recognition by approving products too quickly and with limited data in some instances, Hahn said the agency must “maintain the vital balance between the speedy approval of new products and the integrity of the data and the process itself.” Noting that the agency is “operating in a time of unsurpassed scientific and technological innovation. I look to further advancing scientific and medical progress with you and to ensuring that we provide the support and information about our regulatory requirements to innovators.”

Additionally, Hahn said that empowering patients and consumers to provide input on regulatory decisions is a priority. “Specifically, I believe there is great promise in the effective use and integration of patient-level data or real world evidence such as electronic health records, clinical trials, medical studies, and patient registries,” he said. Hahn said the agency needs to do more work to make its Patient-Focused Drug Development initiative more successful, adding that he looks forward to engaging and hearing from stakeholders, including those representing patients, families, consumers, and health professional organizations.

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