Drugs

Clinical Trial Meta-Analysis Guidance Out

FDA has published a draft guidance, Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products, to describe the factors FDA intends to consider when evaluating the strength of evidence provided by a meta-analysis studying the safety of drugs. The document includes Introduction, Background and Scope, The Quality and Relevance of Candidate Trials, The Importance of Prespecification and Transparency, Statistical Methodology Considerations, Strength of Evidence and Regulatory Decisions, Examples, and References.

Commenting on the guidance, FDA commissioner Scott Gottlieb said the agency wants to encourage more pooled studies to evaluate important safety events. “Meta-analyses can be conducted in the pre- and post-market setting, and the recommendations in this draft guidance, when finalized, will apply to both,” he said. “Sponsors apply the principles described in this draft guidance when planning and conducting a meta-analysis of randomized controlled trials to better assess the safety of a drug product.”

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