Drugs

FDA Expanding Covid Work with Aetion

FDA is expanding its relationship with Aetion to use real-world evidence (RWE) to study Covid-19 interventions and advance regulatory science and innovation. Aetion says the agency and company will use the Aetion evidence platform to develop a framework and system of studies for the rapid assessment of Covid-19 inpatient medical products.

“This project is designed to demonstrate how using a platform-based approach furthers regulatory learnings on the use of RWE to inform decision-making,” the company says. “The work will also provide a scalable infrastructure for the rapid development and evaluation of Covid-19 therapies, which can be applied for future public health emergencies.”

In a research collaboration announced 5/2020, FDA and Aetion explored the utility of real-world data (RWD) to advance the understanding of and response to Covid-19. The two say they have developed mechanisms to assess data fitness for use; identified methodological good practices on working with RWD for Covid-19, and built the foundation for rapid-cycle analytics to address critical and emergent public health questions.

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