Drugs

FDA Safety Assessment, Reporting Guidance Analyzed

Five King & Spalding attorneys say an FDA draft guidance on safety event analysis and reporting for IND and bioavailability/bioequivalence studies signals the agency’s “current attention on the IND sponsor’s analysis of adverse events that may require expedited reporting to FDA and to all participating investigators.” In an online analysis, the attorneys say the draft particularly emphasizes the agency’s current focus on an aggregate analysis of safety events, including a comparison of the incidence of the event in the investigational drug group and the control group for the determination of a possible causal relationship between the investigational drug and the event.

Although the analysis of a possible causal relationship may require unblinding, the attorneys say, the draft extensively discusses the risk of the unblinding of safety data on the trial’s integrity and potential safeguards to mitigate the risk. “Sponsors may wish to carefully review the recommendations related to aggregate safety data analyses and crosswalk FDA’s recommendations to current processes within the company for safety surveillance, including unblinding for analysis of safety events, in IND investigations,” they write.

FDA also proposes that sponsors develop a formal written prospective plan for safety surveillance that is specific to the premarket development program for the investigational drug and subject to FDA inspection.

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