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Posted On: 09/16/2021 4:13:26 PM
Post# of 36541
I also read this. We know that the IND was to be submitted a while back . Does this mean it it was submitted and if they haven’t heard back in 30 days they could have started the clinical trials ? Is there some place we can see if they have started clinical trials ?
Once an IND is submitted, the FDA has 30 days to object to the IND or it automatically becomes effective and clinical trials may begin. If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the problem is resolved.
Once an IND is submitted, the FDA has 30 days to object to the IND or it automatically becomes effective and clinical trials may begin. If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the problem is resolved.
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