Attachment III - Page 8 
BUREAU OF DRUGS 
GUIDE 
BD 4831.1 ATTACHMENT/; 
i. This is a deficiency that must be corrected and the corrective 
action reviewed and approved by the Agency before the study is 
started. 
10. IND Review of a Completed Study . This review would begin with a 
description of the protocol and the study objective (similar to the 
Resume of the protocol review above). The study would then be 
reviewed as outlined under the NDA Medical Review Guideline, Section 
5 a (4) (a) (b) (c) and (d) and 5 b. 
CT HO. 
BD 80-23 (8/14/80) 
T7ZT 
8 
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