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    FDA Finalizes Guidance on Overfilling Injectable Vials

    New guidance just issued by the US Food and Drug Administration (FDA) calls on pharmaceutical and biopharmaceutical companies to more closely control the amount of excess product contained in vials of injectable drugs and biologics. Background Liquid products must often be administered through an intermediary device, such as a syringe. Unlike a solid pharmaceutical tablet, which contains the full dose of the product in solid form, a vial of liquid product usually cont...
  • Citing Safety Concerns, FDA Guidance Takes Aim at Practice of Overfilling Injectable Vials

    The US Food and Drug Administration (FDA) today issued a new draft guidance document clarifying its standards for filling injectable drugs and biological products. Background Liquid products must often be administered through an intermediary, such as a syringe. Unlike a solid pharmaceutical tablet, which contains the full dose in solid form, a vial of liquid product usually contains more than the recommended dose since it may be difficult or impossible to remove 100% ...