Drugs

Real-World Evidence Framework is ‘Good Foundation’: Merck

Merck says the FDA Framework for FDA’s Real-World Evidence Program, which fulfills the 21^st Century Cures Act requirement for the agency to establish a program to evaluate potential use of real-world evidence to help support approval of a new indication for a drug approved under section 505(c) and to help support or satisfy post-approval study requirements “provides a good foundation for exploring the full potential of real-world evidence for regulatory decision making and welcomed insight on FDA’s current views on this important topic.” The company’s comment letter offers suggestions to strengthen the framework to (1) clarify how real-world evidence might meet the evidentiary requirements for regulatory decisions; (2) identify and strengthen opportunities for shared learning under the Framework; and (3) explore demonstration projects.

ISPOR, the professional society for health economic and outcomes research, congratulates FDA for producing a comprehensive implementation outline for its real-world evidence program. It says that real-world data and real-world evidence “are key building blocks to understanding real-world usage and effects of pharmaceutical products.” The society also provides specific comments on sections that are particularly relevant to its members’ mission.

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