Drugs

Workshop on Study Risk-Based Monitoring

FDA has announced a 7/17 public workshop entitled “Improving the Implementation of Risk-Based Monitoring (RBM) Approaches of Clinical Investigations.” The workshop is intended to capture stakeholder experiences with risk-based approaches to monitoring of clinical investigations and gather stakeholder input on opportunities to further implement risk-based approaches to monitoring.

The workshop is based on recommendations in a 3/15 draft guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.” FDA says that traditionally sponsors and research organizations have depended upon on-site monitoring and 100% source data verification for each clinical site, an approach that is resource intensive and may contribute to increased clinical trial costs. “Adoption of RBM could lead to improvements to human subject protections, data integrity, and the efficiency of clinical investigations,” an FDA notice says. “Data suggest that RBM has not yet been widely implemented. Therefore, FDA is seeking additional feedback from stakeholders on the challenges, barriers, and enablers that might be impacting the adoption of RBM.”

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