In the midst of the Zarxio (filgrastim-sndz) biosimilar review, FDA inadvertently sent a CMC-related information request intended for the product’s sponsor, Sandoz Inc., to another entity.
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Sorry, Wrong Email: FDA’s ‘Oops’ Moment In The Zarxio Review
Misdirected CMC-related information request prompts FDA apology to Sandoz over inadvertent disclosure.