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HDGabor

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HDGabor

Re: redlyon post# 31216

Sunday, 07/27/2014 1:53:06 PM

Sunday, July 27, 2014 1:53:06 PM

Post# of 423943
See post #28220 and Guidance for Clinical Trial Sponsors, but shortly:
- "To avoid any influence of interim data on consideration of protocol changes, FDA staff will also generally remain blinded to the interim results."
- "In rare cases, we [FDA] may wish to interact with a DMC ..."
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