INDs and NDAs - code of federal regulation

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Al,

PART 312-INVESTIGATIONAL NEW DRUG APPLICATION

http://bit.ly/ifp2dy

and PART 314-APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

http://bit.ly/f8TzNT

links to related code:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm090410.htm