Safety Worries Prompt FDA Update On Injectables Dosing

Law360, New York (March 13, 2014, 2:28 PM EDT) -- The U.S. Food and Drug Administration on Thursday took aim at overfilled drug vials it says are contributing to hazardous conditions for patients, issuing guidance that describes acceptable excess quantities and how they may affect product approvals.

In its seven-page guidance, the FDA explored overfill issues surrounding injectable products packaged in vials and ampules, but not in other packaging types, such as prefilled syringes or intravenous infusion bags.

According to regulators, sloppy product handling and poor injection practices that can cause infections are often linked to...
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