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비즈니스 · 2003. 9. 15.1 분 읽기
Guidance for Industry on Investigational New Drug Application Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer; Availability
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer." This guidance clarifies FDA's policy on exemption from investigational new drug application (IND) requirements for studies of marketed cancer drug or biological products. This guidance is intended to decrease the submission of unnecessary IND exemptions.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →