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The agency issued a draft guidance document on the requirements for submission of applications for liposome drug products.
FDA issued draft guidance on Oct. 29, 2015 addressing the agency’s requirements for the submission of new drug applications (NDA), abbreviated new drug applications (ANDA), or biologic license applications (BLA) for liposome drug products to the Center for Drug Evaluation and Research. The new draft guidance replaces Draft Guidance for Industry, Liposome Drug Products, Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation published in August 2002.
The guidance, prepared by CDER’s Liposome Working Group, discusses chemistry, manufacturing, and controls (CMC); human pharmacokinetics and bioavailability or, in the case of an ANDA, bioequivalence; and labeling in NDAs and ANDAs. It focuses on the unique technical aspects of liposome drug products, but does not provide recommendations on clinical efficacy and safety studies, nonclinical pharmacology/toxicology studies, or drug-lipid complexes. The guidance may also be applicable to biological liposome products reviewed by CDER’s Office of Biotechnology Products.
FDA states that recommendations in the guidance “should be considered during drug development that may lead to the submission of an investigational new drug application (IND) for a liposome drug product.” And, in connection with ANDA submissions, recommendations in any product-specific bioequivalence guidance should be considered, “including bioequivalence and information necessary to demonstrate pharmaceutical equivalence to the reference listed drug.”