Docket Number:
FDA-2016-D-2817
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance discusses what types of information you, the applicant, should submit in your new drug application (NDA) or abbreviated new drug application (ANDA) for a liposome drug product reviewed by the Center for Drug Evaluation and Research (CDER). 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.

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All written comments should be identified with this document's docket number: FDA-2016-D-2817.