Drugs

Liposome Drugs Guidance Out

FDA has released a guidance, Liposome Drug Products Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation, to cover what types of information applicants should submit in NDAs or ANDAs for a liposome drug product reviewed by CDER. The document finalizes a 10/2015 draft. The agency says that recommendations in the guidance focus on the unique technical aspects of liposome drug products and do not provide recommendations on clinical efficacy and safety studies, nonclinical pharmacology/toxicology studies, or drug-lipid complexes.

“Although this guidance does not provide recommendations specific to liposome drug products to be marketed under BLAs,” FDA says, “many scientific principles described in this guidance may apply to these products.”

Guidance recommendations should be considered during development that may lead to submission of an IND for a liposome drug product, the agency says. And in connection with ANDAs, applicants should consider recommendations in any product-specific guidance, including bioequivalence and information necessary to demonstrate pharmaceutical equivalence to the reference-listed drug.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome