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mypekeispooped

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mypekeispooped

Re: jckrdu post# 91228

Thursday, 01/24/2019 12:13:56 AM

Thursday, January 24, 2019 12:13:56 AM

Post# of 108192
"The amount of CMC information needed varies
according to type of trial
– Phase, Size and Duration of clinical trial, Dosage
form, Prior Usage, History, etc."

https://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm301050.pdf
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