EN PL

FDA: Draft - Guidance for Industry Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products

20.03.2014
This draft guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current thinking on allowable excess volume and labeled vial fill size in injectable drug and biological products.