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Re: groverdongles post# 2471

Wednesday, 05/12/2021 1:46:08 PM

Wednesday, May 12, 2021 1:46:08 PM

Post# of 13742
IND Application Procedures: Overview...

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-overview#:~:text=An%20IND%20application%20may%20go%20into%20effect%3A%2030,the%20application%20are%20subject%20to%20a%20Clinical%20

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.

Once an IND application is in effect, a drug manufacturer may ship the investigational new drug to the investigator(s) named in the application. An investigator may not administer an investigational new drug to human subjects until the IND application goes into effect.

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