Drugs

FDA Steps to Modernize Clinical Trials

FDA commissioner Scott Gottlieb says recent guidances are part of an effort to modernize clinical trials to take advantage of novel opportunities such as trials in which small groups of patients are selected based on biomarkers or other criteria suggesting they are likely to benefit. In a statement, Gottlieb says the advent of precision medicine “is challenging the entire medical research ecosystem to develop more efficient approaches to testing and developing diagnostics and therapeutics, to harness the full potential of science to reduce the suffering, death, and disability caused by complex human illnesses.”

Despite FDA’s work with stakeholders, Gottlieb says, there still is a continued reluctance demonstrated by some sponsors and clinical research organizations to adopt innovative approaches. “In some cases,” he says, “the business model adopted by the clinical trial establishment just isn’t compatible with the kind of positive but disruptive changes that certain innovations can enable. We appreciate that scientific and technical complexity is a real and ongoing challenge, but industry and academia also need to invest in and leverage these approaches and develop new incentives that reward collaboration and data sharing across the clinical research enterprise.

Guidances recently issued in support of these goals include incorporating patients with more challenging health conditions in oncology trials, enrichment strategies for clinical trials, a risk-based approach to monitoring clinical investigations, and nonclinical development of pharmaceuticals for some hematologic disorders.

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