Biologics

FDA Promoting ‘Pragmatic Clinical Research’: Califf

FDA commissioner Robert Califf and two agency colleagues say FDA is interested in pragmatic clinical research as a “middle path between traditional randomized clinical trials and observational evidence to inform decisions about the use of medical products after initial market approval.” Writing in a JAMA Viewpoint, the three say pragmatic clinical research should be leveraged to answer questions about medical products in the context of real-world clinical practice with appropriate transparency and ethical safeguards.

The article says such research uses real-world data, often combining it with data collected specifically for research. “It features streamlined, prospective trial designs fit for answering a specific, focused question and often applies randomization, although other designs may be used,” the executives say. “Such research holds special promise when embedded in healthcare systems, where it can help investigators avoid some of the most critical drawbacks of ‘traditional’ clinical trials, such as substantial, sometimes prohibitive costs, as well as the loss of diverse representation that can arise from conducting trials in environments that are unrepresentative of all clinical practice settings and patient populations.”

The article concludes that pragmatic clinical research can inform regulatory decisions, while also supporting patients, clinicians, health systems, and payers in assessing the comparative effectiveness of treatments and making determinations about the relative value of different interventions.

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