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비즈니스 · 2005. 9. 19.1 분 읽기
Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Extension of Application and Comment Deadlines
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA) is announcing an extension in the deadlines for submitting requests to participate in and comment on a pilot program involving the submission of chemistry, manufacturing, and controls (CMC) information consistent with the new pharmaceutical quality assessment system.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →