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비즈니스 · 2006. 3. 15.1 분 읽기
Guidance for Industry on Nonclinical Safety Evaluation of Drug or Biologic Combinations; Availability
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Nonclinical Safety Evaluation of Drug or Biologic Combinations." This guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products (FDCs), co-packaged products, and some adjunctive therapies.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →