Drugs

Pharmacokinetics for Impaired Renal Function Guidance

FDA has issued a draft guidance, Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis, and Impact on Dosing, to assist sponsors in the design and analysis of studies assessing the influence of impaired renal function on pharmacokinetics and/or pharmacodynamics of an investigational drug. The document also addresses how such information can inform the drug’s labeling.

The draft revises and replaces a 3/2010 draft guidance and provides updated recommendations on:

when a standalone study of a drug’s pharmacokinetics in subjects with impaired renal function is recommended and when it may not be needed;
the design and conduct of pharmacokinetic studies in subjects with impaired renal function;
considerations for characterizing a drug’s pharmacokinetics in patients undergoing intermittent or continuous dialytic therapies;
the use of pharmacokinetic information from Phase 2 and 3 studies to inform dosing recommendations for patients with impaired renal function; and
the analysis and reporting of the results of studies that characterize the impact of impaired renal function and how these data inform dosing recommendations in labeling.

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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