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Formatting, Assembling, and Submittingthe New Drug Application (NDA)
Agnimitra DindaSchool of Pharmaceutical SciencesBhubaneswarINDIA
 
 
Introduction:• The new drug application (NDA) is acritical component in the drugapproval process. The U.S. Food andDrug Administration (FDA) requiresdrug sponsors to submit an NDA forreview before a new pharmaceuticalcan be approved for marketing andsale in the U.S.• The NDA contains clinical andnonclinical test data and analyses,drug chemistry information, anddescriptions of manufacturing
 
 
FDA Guidelines:
•NDA shares many commonelements with the Common Technical Document (CTD)developed by the InternationalConference on Harmonization (ICH)in order to streamline submissionsfor registration in all three ICHregions: the U.S., the EuropeanUnion, and Japan.
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