Determination of Regulatory Review Period for Purposes of Patent Extension; ENHERTU; Correction

摘要

The Food and Drug Administration (FDA or the Agency) published a notice in the Federal Register of November 1, 2021, for the determination of a regulatory review period for purposes of patent extension for the human biological product, ENHERTU. This document corrects that notice by adjusting the applicable regulatory review period for the testing phase and approval phase of the product, ENHERTU.