FDA Latest Industry Guidance for Liposome Drug Products
Liposome Drug Products Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation Guidance for Industry It provides specific labeling requirements for liposome versus pegylated liposome. The nonproprietary name of a drug product approved under the Federal Food, Drug, and Cosmetic Act is its established name, which , in most instances , will be […]