Drugs

Pazdur Explains New Cancer Trial Guidance

FDA Oncology Center of Excellence director Richard Pazdur says a draft guidance, Use of Expansion Cohorts in First-in-Human Clinical Trials to Expedite Development of Cancer Drugs and Biologics, published 8/2018, is intended to “help advance effective and innovative clinical trial designs early in drug development to help bring new cancer therapies to patients as quickly as possible.” In an FDA Voice blog post, Pazdur summarizes the guidance provisions, saying that “trials with multiple expansion cohorts can be inherently more efficient and expedite early drug development. They can address multiple questions in a single trial that is amended as new objectives are identified, avoiding the time lag and additional resources experienced with the opening of new clinical trials.”

Pazdur says the agency wants stakeholder input to make sure that the final guidance is comprehensive and forward-looking and adapts to rapidly changing research developments and technologies. “Our regulatory work needs to remain as advanced as the many new cancer therapies currently working their way through development,” Pazdur concludes.

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