ARTICLE | Politics & Policy
CDER releases guidance on liposome products
April 4, 2018 11:04 PM UTC
FDA's Center for Drug Evaluation and Research released final guidance Wednesday regarding what information companies should include when submitting an NDA or ANDA for liposome drug products, including CMC information.
The agency recommended that applications list all product components, including drug substance and lipid components, as well as the amount and specific physiochemical properties of each lipid component...