Guideline Updates

Guideline Updates   FDA issues new draft guidelines for  Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products

 

The US Food and Drug Administration (FDA) yesterday (13/03/14) issued a new draft guidance document (Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products) clarifying its standards for filling injectable drugs and biological products.

This draft guidance clarifies the FDA regulatory requirements and recommendations pertaining to allowable excess volume in injectable vials and describes when justification is needed for a proposed excess volume in these injectable drug products.