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BioPharmaceutical Approvals

The Perils Of A Pre-Filled Syringe: Device Issues Delayed Tbo-filgrastim

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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