Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation." This guidance document finalizes the revised draft of the same name that published on October 30, 2015. This guidance provides recommendations to applicants on the chemistry, manufacturing, and controls (CMC); pharmacokinetics and bioavailability; and labeling documentation for liposome drug products submitted in new drug applications (NDAs) and abbreviated new drug applications (ANDAs), reviewed by the Center for Drug Evaluation and Research (CDER).