Drugs

Population Pharmacokinetics Draft Guidance

FDA has published a draft guidance, Population Pharmacokinetics, to assist NDA and BLA sponsors to apply population pharmacokinetic (population PK) analysis. The document says population PK is frequently used to guide drug development and inform recommendations on therapeutic individualization, such as through tailored dosing. “Adequate population PK data collection and analyses submitted in marketing applications have in some cases alleviated the need for postmarketing requirements or postmarketing commitments,” it says.

The guidance includes common applications of population PK analysis to inform drug development and drug use. It also includes the agency’s current thinking on the data and model requirements needed to support regulatory decisions, recommendations to sponsors on drug labeling based on population PK analysis, and the general expectations about the format and content for population PK reports to FDA.

Guidance topics are Introduction, Background, Application of Population PK Analysis, Data Used for Population PK Analysis, Data Analysis, Labeling Based on the Results of Population PK Analysis. Population PK Study Reporting, Glossary of Selected Terms, and References.

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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