Drugs

Oncology Center Pact on Real-world Evidence

FDA’s Oncology Center of Excellence and real-world evidence company Syapse say they have renewed a four-year agreement to collaboratively develop and implement specific research projects to “advance the use of real-world data (RWD) and explore the potential strengths and limitations of using real-world evidence to inform regulatory objectives.” The partnership is intended to evaluate RWD study designs and analytic methods, and develop clinically meaningful research questions about care, treatment, and outcomes for cancer patients.

Specifically, Syapse says the next four years will see the collaboration:

Explore approaches to define and assess fit-for-purpose relevant data on treatment exposure, patient outcomes, and covariates required to answer specific questions of interest;
Analyze Syapse’s Learning Health Network data to explore fit-for-purpose RWD, create real-world study protocols using best pharmacoepidemiology practices, and conduct observational studies; and
Use novel oncology data sources to support the collaboration’s evaluation of RWD sources for evidence generation.

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