Drugs

Renal PK Study Guidance

FDA has published a guidance, Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing, to assist sponsors in designing and analyzing studies assessing the influence of impaired renal function on the pharmacokinetics (PK) and/or pharmacodynamics of an investigational drug. The document also provides recommendations on determining the recommended dosage in patients with impaired renal function and addresses how such information can inform the labeling, including:

when a standalone study to address a drug’s PK in participants with impaired renal function is recommended and when it may not be warranted
the design and conduct of PK studies in participants with impaired renal function;
considerations for characterizing a drug’s PK in patients receiving intermittent or continuous renal replacement therapies;
using information from Phase 2 and 3 studies to characterize the impact of renal function on PK and/or drug effects in patients with impaired renal function;
considerations for deriving dosage recommendations for patients with impaired renal function; and
analysis and reporting of study results that characterize the impact of impaired renal function and how these data inform dosing recommendations in 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