Friday, 14 March 2014

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The US Food and Drug Administration (FDA) yesterday (13/03/14) issued a new draft guidance document (Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products) clarifying its standards for filling injectable drugs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This draft guidance clarifies the FDA regulatory requirements and recommendations pertaining to allowable excess volume in injectable vials and describes when justification is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.
 
 

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