비즈니스 · 2021. 6. 11.1 분 읽기
Determination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO; Correction
로컬 자동 번역 · 원본 출처 언어
요약
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.