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Re: otto17 post# 116042

Saturday, 02/15/2020 2:13:22 PM

Saturday, February 15, 2020 2:13:22 PM

Post# of 144820
One lengthy part of the IND application preparation may result from the FDA statement:

Once an IND application is in effect, a drug manufacturer may ship the investigational new drug to the investigator(s) named in the application.

ie., all investigators named: does that mean just Dr. Hidalgo or all the lead Drs at the participating sites.
I ask because the FDA follows by stating:

An investigator may not administer an investigational new drug to human subjects until the IND application goes into effect.

Dr Hidalgo isn't going to be administering the drug at all sites. Implying to me that all site investigators must be 'on board' and named before the IND should be submitted?
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