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비즈니스 · 2023. 8. 24.1 분 읽기
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Alternative Form of Hearing
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA) announces an alternative form of hearing regarding the Center for Drug Evaluation and Research's (CDER's) proposal to refuse to approve ITCA 650 (exenatide in DUROS device), a drug-device combination product that is the subject of a new drug application (NDA) submitted by Intarcia Therapeutics, Inc. (Intarcia). CDER is holding a public hearing before an advisory committee under FDA regulations as an alternative form of hearing.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →