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Re: None

Thursday, 01/05/2017 12:37:26 PM

Thursday, January 05, 2017 12:37:26 PM

Post# of 410433
Companies wait to release detailed info until the after release of the minutes because the FDA may add things to the minutes for clarification

"Before the end of the meeting, FDA attendees and the sponsor or applicant attendees should summarize the important discussion points, agreements, clarifications, and action items. Generally, the sponsor or applicant will be asked to present the summary to ensure that there is mutual understanding of meeting outcomes and actions. FDA staff can add or further clarify any important points not covered in the summary and these items can be added to the meeting minutes. The summary can be done at the end of the meeting or after the discussion of each question."

THIS IS TAKEN FROM FDA RULES REGARDING MEETINGS WHICH IS WHY COMPANIES WAIT FOR MINUTES TO BE RELEASED BEFORE GOING INTO DETAIL

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm153222.pdf

idleness is the only refugee of weak minds

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