Drugs

Use Risk Assessments on Trial Monitoring Decisions: FDA

FDA has added information in a revised guidance about remote monitoring of clinical trials conducted during the Covid emergency and whether onsite monitoring should audit the remote monitoring once Covid restrictions are lifted. The re-monitoring discussion is contained in the appendix and the just-revised guidance entitled Conduct of Clinical Trials of Medical Products During the Covid-19 Public Health Emergency.

The document notes that FDA regulations require sponsors to monitor the conduct and progress of their clinical investigations, but they are not specific about how sponsors must conduct such monitoring, which means there are many approaches that may vary depending on multiple factors. “The decision as to whether remote monitoring conducted for a given site or clinical investigation was adequate or should be followed up with additional on-site monitoring visits should be based on the sponsor’s ongoing risk assessment,” the guidance says. “The sponsor may determine that on-site follow-up of remote monitoring activities is appropriate based on a risk assessment (e.g., sites with certain data anomalies or a higher frequency of errors, important protocol violations, or dropouts relative to other sites). As with on-site monitoring, remote monitoring should be focused on critical data and processes for human subject protection and trial integrity, such as the site’s conduct of key study procedures and documentation related to important efficacy endpoints and safety assessments.”

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