Drugs

Improve Post-Market Evidence Generation: Report

A new Reagan-Udall Foundation report, “Enhancing Post-Market Evidence Generation for Medical Products,” addresses barriers, proposes solutions, and makes recommendations to FDA and other stakeholders that aim to facilitate evidence generation in the postmarket setting. The report defines pragmatic evidence generation as conducting prospective clinical studies of medical products already on the market for at least one indication.

It says a pragmatic evidence generation system requires health systems, sponsors, administrative/regulatory systems, funders, payers, and FDA to:

design pragmatic, resource-efficient studies that resolve evidence gaps and generate clinically meaningful results that affect clinical practice;
streamline data collection as much as possible while ensuring that data quality and completeness are acceptable for regulatory purposes;
provide opportunities and incentives to the entire patient care team to engage in pragmatic evidence generation;
prioritize studies based on public health needs and gaps in clinical evidence; and
engage relevant stakeholders to address who decides the priorities for knowledge 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