Drugs

Covid Trial Statistical Considerations Guidance

FDA has issued an immediately-in-effect guidance, Statistical Considerations for Clinical Trials During the Covid-19 Public Health Emergency, to address the impact of Covid-19 on meeting trial objectives for clinical trials conducted during the duration of the public health emergency. The document outlines considerations for the statistical analysis of the primary and key secondary endpoints in a trial affected by Covid-19 to help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty.

The agency says the guidance addresses statistical considerations for proposed changes to trial conduct that may affect the analysis and interpretation of the primary or key secondary endpoints in the trial. “FDA recommends that sponsors consult with the relevant FDA review division when considering protocol changes and changes to the statistical an analysis plan that may impact the analysis and interpretation of these endpoints,” the guidance says. The document covers trial integrity and trial mitigation and analysis strategies.

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