Devita, Hellman, and Rosenberg's Cancer

(Frankie) #1

LWBK1006-47 LWW-Govindan-Review December 12, 2011 20:55


588 DeVita, Hellman, and Rosenberg’s CANCER: Principles and Practice of Oncology Review

Answer 47.16. The answer is D.
Unless in the case of an approved waiver, sponsors should wait 30 days
after receiving the IND approval to initiate the study. All studies on non-
approved drugs require IND, whereas studies on approved drugs may be
exempted. The IND spans the entire process of drug investigation.
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