Drugs

FDA Promotes Dose Optimization Innovation: Report

Six FDA researchers say alternative trial designs and analytical methods with an iterative process that leverages nonclinical data and clinical observations beyond short-term safety data are needed to identify optimized dosages for newer oncology drugs, given that targeted therapies and immunotherapies often do not demonstrate traditional dose-limiting toxicities and meaningful clinical activity may be observed at dosages lower than the maximum tolerated dose.

Writing in CPT: Pharmacometrics and Systems Pharmacology, the researchers say FDA is increasingly interested in implementing model-informed clinical trial designs.

“Although these approaches are relatively new compared with traditional toxicity-driven dose-finding trials, they may allow for more informative dose selection in situations where non-clinical data, same-in-class drug information, or emerging clinical data can be maximally leveraged,” they write. They also say the agency is interested in the adoption of seamless, adaptive designs to address key questions around optimized dosage, safety, and efficacy determination.

The researchers say FDA scientists work collaboratively to provide regulatory advice on specific regulatory submissions, drug development programs, drug development tools, and novel approaches in a variety of forums.

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