Drugs

Clarity in RWE Guidance is Welcome: Attorneys

FDA’s new draft guidance on “Real-World Evidence (RWE): Considerations Regarding Non-Interventional Studies for Drug and Biological Products” provides “additional clarity” on the agency’s focus when analyzing a RWE program’s adequacy, according to an online post from attorneys at Hogan Lovells. “Notably, unlike previous guidances on the topic, FDA specifies that non-interventional studies can be used to support a demonstration of substantial evidence of effectiveness and/or the safety of a drug,” they write. “Although this may have been implied in the agency’s use of ‘regulatory-decision making’ in earlier RWD/RWE guidances, specifying the substantial evidence standard may indicate FDA is open to placing more reliance or weight on RWE when determining the approvability of a drug or biologic product, including establishing the risk/benefit profile.”

The document provides recommendations for sponsors and investigators who are considering submitting a non-interventional study to the agency to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of the safety of a drug. It specifically discusses attributes regarding the design and analysis of a non-interventional study that sponsors should consider when proposing a non-interventional study for such regulatory purposes.

The post says that due to FDA’s additional clarity on RWE, the agency is “acknowledging the impact that data from electronic health records, medical claims, disease registries, and digital drug development tools can have on approval decisions. Consistent with prior guidance, when seeking to incorporate RWD to support regulatory decisions for product development, sponsors should consult with FDA early in the planning of a study to discuss FDA expectations for design and conduct.”

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