Biologics

FDA Schedules Sentinel PRISM 12/7 Workshop

FDA has scheduled for 12/7 a public workshop, “The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program,” to describe the Sentinel Initiative and PRISM program, illustrate how the agency uses PRISM for regulatory responsibilities, and discuss PRISM’s future direction in terms of expansion and further integration into the regulatory review process. A 9/1 Federal Register notice says that PRISM was initiated in 2009 as one of several national vaccine safety surveillance systems deployed during the H1N1 influenza pandemic. It was integrated into the Sentinel Initiative in 2010 and has been used on multiple occasions to evaluate for vaccine-adverse events.

FDA says that the workshop will bring together other government agencies, academia, industry, and other stakeholder participants involved in vaccine development and safety to consider (1) the available data infrastructure, (2) methods, and (3) tools. Representative examples of PRISM studies will be presented, FDA says, to demonstrate the program’s success in safety signal refinement and evaluation and in informing the regulatory process. There also is to be a discussion of possible future PRISM directions.

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