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비즈니스 · 2019. 3. 28.1 분 읽기
Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling; 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 "Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling." This guidance is intended to assist applicants in determining the appropriate placement and content of pediatric information in human prescription drug and biological product labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products. This guidance finalizes the draft guidance issued on February 28, 2013.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →