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.
Sorry, Wrong Email: FDA’s ‘Oops’ Moment In The Zarxio Review
Misdirected CMC-related information request prompts FDA apology to Sandoz over inadvertent disclosure.