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비즈니스 · 2019. 8. 15.1 분 읽기
Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment; Guidance for Industry; Availability
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment." The purpose of this guidance is to provide recommendations to industry for designing nonclinical bone quality studies to support the approval of drugs and biologics (e.g., recombinant proteins and monoclonal antibodies regulated by the Center for Drug Evaluation and Research) intended for the treatment of osteoporosis.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →