FDA Finalizes Guidance on Liposome Drugs
The US Food and Drug Administration (FDA) on Wednesday finalized a revised draft guidance from 2015 on the unique aspects and the types of information sponsors should submit for new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for liposome drug products.The 18-page guidance discusses the following topics for liposome drug products: (A) chemistry, manufacturing, and controls (CMC); human pharmacokinetics and bioavailability or, in the case of an ANDA, bioequivalence and labeling.
Sections of the guidance also touch on descriptions and composition, physicochemical properties, critical quality attributes, description of manufacturing process and process controls, control of lipid components, drug product specification, stability and postapproval changes in manufacturing.
FDA noted that most of the changes to the 2015 revised draft guidance were made to clarify statements from a 2002 draft, and this latest finalized version reflects FDA’s consideration of comments
The guidance does not provide recommendations on clinical efficacy and safety studies, nonclinical pharmacology and/or toxicology studies, liposome formulations of vaccine adjuvants or biologics or drug-lipid complexes.
Liposome Drug Products Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation Guidance for Industry