Drugs

Researchers Examine Modeling for Pediatric Dose Selection

FDA researchers are working with industry and clinicians to determine the best way to apply modeling information to improve pediatric dose selection for renally eliminated drugs in the pediatric patient population. A new CDER Web posting notes recent research findings that renal function models and equations are “valuable tools for predicting drug pharmacokinetics, clearance, and dose adjustments in pediatric patients. Although the clearance of renally eliminated drugs might be overestimated when using creatinine-based renal function equations — especially for pediatric patients with low levels of serum creatinine — well-reasoned adjustments to methods of calculating eGFR [estimated glomerular filtration rate] values may improve the accuracy of predicted parameters. Equations based on cystatin C levels or a combination of multiple renal biomarkers might be productive in this regard.”

FDA says its research will inform efforts to “improve pediatric dose selection strategies for drug developers as well as pediatricians who must pay particular attention to renal function. The research project has also had a significant impact on pediatric drug regulatory review by facilitating consensus on best practices for assessing pediatric renal function and dose selection in clinical trials and product labeling.”

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