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 Tushar Premchandani 1
INVESTIGATIONALNEW DRUG (IND) TusharPremchandani,NMIMS, Shirpur
 
2Tushar Premchandani
Introduction
An Investigational New Drug Application (IND)is asubmission to the Food and DrugAdministrationrequestingpermission to initiatea clinical studyof a new drug product.
The Federal Food, Drug, and Cosmetic Actrequires thatall drugs have an approvedmarketing application(NDA, BLA, ANDA) before they can be shipped in interstatecommerce.
 
3Tushar Premchandani
The IND applicationallows a company toinitiate and conductclinical studies of their new drug product.
The IND applicationprovides the FDAwith the datanecessary to decidewhether thenew drug and the proposedclinical trial pose a reasonable risk to thehuman subjectsparticipating in thestudy.
Introduction
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