• 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    The US Food and Drug Administration (FDA) today issued a new draft guidance document clarifying its standards for filling injectable drugs and biological products.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% ...