The Perils Of A Pre-Filled Syringe: Device Issues Delayed Tbo-filgrastim
This article was originally published in Pharmaceutical Approvals Monthly
Choosing an established, off-the-shelf pre-filled syringe as the device to deliver its granulocyte colony-stimulating factor tbo-filgrastim proved no safeguard to Teva during FDA‘s meticulous review of the BLA.
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