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Posted On: 07/19/2021 8:33:16 PM
Post# of 36541
Hopefully, around one month at the latest after the IND is submitted it’s approved.
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Upon receipt of an IND application, FDA will notify the sponsor of the date it receives the application through an IND acknowledgment letter.
An IND application may go into effect:
30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or
on earlier notification by FDA that the clinical investigations in the IND may begin.
https://www.fda.gov/drugs/investigational-new...s-overview
—-
Upon receipt of an IND application, FDA will notify the sponsor of the date it receives the application through an IND acknowledgment letter.
An IND application may go into effect:
30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or
on earlier notification by FDA that the clinical investigations in the IND may begin.
https://www.fda.gov/drugs/investigational-new...s-overview
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