FDA Policy/General

FDA Regulatory Science Report Signals Top Priorities

A new FDA report identifies four regulatory science strategic initiatives for 2021 — unleashing the power of data; increasing choice and competition through innovation; empowering patients and consumers; and public health emergency preparedness and response. The Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science report was developed to “identify and communicate priority areas where new or enhanced investments in regulatory science research capacity are essential to support FDA’s regulatory and public health mission,” the agency says. Increased research in these areas is intended to aid in innovative product development, provide data to inform regulatory decision-making, and improve guidance to sponsors, it says.

The report discusses the importance of real-world evidence (RWE) in regulatory decision-making, including its ability to provide “fit-for-purpose” clinically meaningful information about the safety and effectiveness of medical products (begins page 39). It outlines several projects that will advance the roles such data can play in supporting the evaluation of a product’s safety and effectiveness, it says. For example, FDA is funding a RWE demonstration project called “Randomized Controlled Trials Duplicated using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology.” The project will attempt to duplicate the results of recently completed randomized controlled clinical trials relevant to regulatory decision-making using RWE, based on health insurance claims data, FDA says.

The report also says FDA is participating in studies focused on understanding how real-world data (RWD) may be able to inform regulatory decisions with external RWD providers. “One objective is to facilitate the use of RWD to learn about the safety and efficacy of FDA-approved oncology drugs in populations generally under-represented in clinical trials,” it says. Additionally, the agency is supporting projects exploring analytic methods that inform RWE, such as machine learning, for drawing conclusions between the occurrence and causes of an adverse event (i.e., causal inference).

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