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要 約
FDA Guidance Document
FDA Guidance #89
INDによらずに実施された国外臨床治験のFDA受理に関してよくある質問
Guidance for Industry: FDA Acceptance of Foreign Clinical Studies , Not Conducted Under an IND ; Frequently Asked Questions. (March 2012. Good Clinical Practice)

Guidance for Industry and FDA Staff
FDA Acceptance of Foreign Clinical Studies
Not Conducted under an IND
Frequently Asked Questions
INDによらずに実施された国外臨床治験のFDAの受理に関して、よくある質問
U.S. Department of Health and Human Services 
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Office of Good Clinical Practice
March 2012

目次
Ⅰ.緒論 [INTRODUCTION]
Ⅱ.背景 [BACKGROUND]
Ⅲ.論議[DISCUSSION]



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