Drugs

FDA Looking for New Real-World Data Uses

CDER director Janet Woodcock and two agency colleagues say FDA is focused on identifying additional areas in which real-world data may be used to generate evidence of effectiveness. Writing in the Journal of the American Medical Association, the three say the effort will require both an assessment of the quality and suitability of underlying data that will be used, and the analytical methods to generate the evidence.

The article says that to better understand how real-world data can be used to inform regulatory questions, the agency’s Oncology Center for Excellence has entered research collaborations to use real-world data to understand the real-world use of new immunotherapies. “These and other FDA projects are assessing the completeness, accuracy, and consistency of electronic health data and will ultimately inform FDA’s assessment of the fitness of these data for use in regulatory studies,” the article says.

Also, to explore how randomized trials can be conducted in real-world settings, FDA is supporting the first randomized clinical trial in the Sentinel system, which so far has only been used to assess safety.

“If real-world data and real-world evidence are to be effectively leveraged for public health purposes,” the report concludes, “there will need to be shared learning and collaboration across clinicians, patients, healthcare systems, pharmaceutical companies, and regulators. Just as the commercial data operators in Sentinel see the value in pooling resources to answer critical safety questions, further collaborations will be needed to create high-quality interoperable networks of data that can be seamlessly leveraged for clinical and research purposes.”

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