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비즈니스 · 1997. 12. 15.1 분 읽기
Product, Establishment, and Biologics License Applications, Refusal to File; Meeting of Oversight Committee
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA) is announcing the 1998 meetings of its standing oversight committee in the Center for Biologics Evaluation and Research (CBER) that conducts a periodic review of CBER's use of its refusal to file (RTF) practices on product license applications (PLA's), establishment license applications (ELA's), and biologics license applications (BLA's). CBER's RTF oversight committee examines all RTF decisions that occurred during the previous quarter to assess consistency across CBER offices and divisions in RTF decisions.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →