PINL:GRPOF - Post by User
Post by
VenturistAllyon Jan 30, 2017 12:23pm
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Post# 25772818
FDA pre-IND
FDA pre-INDAmazing things happening here!!! When are trials officially starting? I think very shortly!! its been moving up recently but i am thinking this is just the start.
"The pre-IND meeting can be very valuable in planning a drug development program, especially if sponsors' questions are not fully answered by guidances and other information provided by FDA. Early interactions with FDA staff can help to prevent clinical hold issues from arising. A pre-IND meeting can also provide sponsors information that will assist them in preparing to submit complete investigational new drug applications. Efficient use of FDA resources can lead to more efficient drug development. "
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069906.htm