The Food and Drug Administration 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 discusses what types of information applicants should submit in a new drug application (NDA) or abbreviated new drug application (ANDA) for a liposome drug product reviewed by the Center for Drug Evaluation and Research. The discussion addresses the following topics for liposome drug products: (A) chemistry, manufacturing, and controls (CMC); (B) human pharmacokinetics and bioavailability or, in the case of an ANDA, bioequivalence; and (C) labeling in NDAs and ANDAs. The recommendations in this guidance focus on the unique technical aspects of liposome drug products. Although the guidance does not provide recommendations specific to liposome drug products to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products.
This guidance finalizes the revised draft guidance for industry of the same name that published on October 30, 2015. FDA published the revised draft guidance due to the need to address changes in technology since the draft was first published in 2002, and to add ANDAs to the scope. FDA received comments in response to the draft and revised draft guidance, and this guidance reflects FDA's careful consideration of those comments.