Drugs

Guidance Shows Importance of Sponsor Oversight: Attorneys

Sidley attorneys say a 4/12 FDA final guidance, A Risk-Based Approach to Monitoring of Clinical Investigations—Questions and Answers, “reinforces the significant expectations for oversight by trial sponsors, the need for them to have a comprehensive quality risk management approach, and the particularly acute obligations for companies that rely heavily on contract research organizations to run their clinical trials.” A Sidley online post says the final guidance aligns with a growing focus on the increasing complexity of clinical trials, their different risk profiles, and good clinical practice concepts articulated by the International Council for Harmonization.

The post says the final guidance goes beyond two earlier draft guidances in these ways:

explicitly articulating the expectations that monitoring is just one component of a comprehensive quality risk management approach;
describing the scope of expected monitoring by placing greater emphasis on the reevaluation of risk assessment and management processes throughout the conduct of the investigation and revision of monitoring plans when needed to continue to protect the rights, safety, and welfare of participants in the clinical investigation and the integrity of data generated during the investigation; and
placing increased emphasis on the monitoring expectations in situations where studies are run by a contract research organization.

“It is perhaps most significant that the new final guidance aligns with growing attention on clinical trials by various stakeholders in the U.S. and globally, a general focus on patient protection and data integrity in clinical investigations, and signals of increased future enforcement,” the attorneys conclude. “In light of all this, clinical trial sponsors should view this new final guidance as significant and further evidence of FDA’s focus on clinical quality and data integrity. While the focus on a risk-based approach is not new, the guidance underlines the importance of robust quality management systems including vendor oversight in the clinical trial context.”

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