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The US Food and Drug Administration (FDA) has published a guidance regarding the liposome drug products.

This Guidance document 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).

This document was released on April 5, 2018.

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