Drugs

Risk-Based Inspection Approach Explained

An Avoca Group white paper defines and describes a risk-based approach to clinical trial inspection readiness, based on activities related to risk-based quality management (RBQM). The paper says RBQM is a “systematic process put in place to identify, assess, control, communicate, and review the risks associated with the clinical trial during its lifecycle.”

A risk-based approach to inspection readiness, Avoca says, can be thought of as a demonstration of intentional, thoughtful, systematic assessment and analysis of the risks. It applies not only to study planning and conduct, but also to inspection preparation and keeping abreast of the specific areas of focus of regulatory agencies worldwide.

“As with other risk-based approaches,” the paper says, “risk-based inspection readiness involves the identification, evaluation, control, review, reporting, and communicating of risks, and especially those risks pertaining to inspections. The aim is to always evaluate risks and focus on mitigating and managing those that will likely have the greatest impact should they manifest.”

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