Sorry, Wrong Email: FDA’s ‘Oops’ Moment In The Zarxio Review
Executive Summary
Misdirected CMC-related information request prompts FDA apology to Sandoz over inadvertent disclosure.
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FDA review documents for Sandoz’s filgrastim-sndz suggest that biosimilar sponsors need to consider how differences in delivery device from the reference product will play out under the 351(k) pathway, including whether new device designs and human factors data will be needed to secure interchangeability.