Drugs

Confusion Exists in RWD/RWE Definitions: Analysis

Nine staff members in various positions in FDA, CDER, and CBER say the terms real-world data (RWD) and real-world evidence (RWE) are often used interchangeably and inconsistently, including in submissions to the agency involving RWE to evaluate the effectiveness of drugs and biologic products. Writing in an open-access commentary in Pharmacoepidemiology & Drug Safety, the authors say that although a misconception sometimes exists that only non-interventional studies use RWD to generate RWE, the spectrum of study designs involves various combinations of data sources and design architecture that determine whether RWE is generated.

“Attempts by various stakeholders to identify the role of RWE in regulatory decision-making often do not focus on the contribution of RWD in specifically evaluating drug-drug interactions,” the article says.

The writers trace the FDA’s use of RWD and RWE and discuss two agency approvals that illustrate how RWD can be used to generate RWE as part of a marketing application for regulatory decision-making.

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