商业 · 2021/6/111 分钟阅读
Determination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO; Correction
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摘要
The Food and Drug Administration (FDA or Agency) published a notice in the Federal Register of February 12, 2018. After review of a timely request for reconsideration by the applicant of the determination of the regulatory review period of the animal drug, BRAVECTO, in that notice, FDA has determined that a revision of the SUPPLEMENTARY INFORMATION section is warranted. This document presents the revised regulatory review period.