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비즈니스 · 2025. 8. 26.1 분 읽기
Determination of Regulatory Review Period for Purposes of Patent Extension; CAMZYOS
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA or the Agency) published a notice in the Federal Register of February 29, 2024. After review of the calculation of the applicable regulatory review period of the biologic product CAMZYOS (U.S. patent numbers 9,181,200; 9,585,883) in that notice, FDA has determined that a revision of the supplementary information section is warranted. This notice corrects the applicable regulatory review period language.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →