Drugs

FDA, Syapse Doing RWE Regulatory Research

The FDA Oncology Center of Excellence (OCE) and Syapse have signed a multi-year research collaboration agreement focusing on using real-world evidence (RWE) to support regulatory decision making. Syapse says that it and OCE “will work with stakeholders across FDA to address key regulatory questions about testing and treatment patterns, dosing and safety, and outcomes in oncology, with a focus on precision medicine.”

As part of this collaboration, Syapse says, it and FDA will investigate methods to derive RWE from multiple sources including, and going beyond, electronic health records (EHRs). “The Framework for FDA’s Real-World Evidence Program describes the challenges in obtaining comprehensive data from EHRs and claims, and the difficulty in linking sources,” the company says. “This collaboration will utilize real-world data integrated from many source systems, including clinical data from EHRs and registries, and molecular data from testing labs, and seek to characterize the regulatory suitability of RWE derived from this multi-source approach.”

Syapse and FDA will also examine real-world endpoints for solid tumors and hematological malignancies, characterizing the usage and clinical impact of molecular testing, understanding outcomes and adverse events in patients receiving precision medicines relative to clinical trial populations, and incorporating patient-reported outcomes into RWE.

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