FDA Approval Process for drug

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IND : Investigational New Drug Application
When New drug is investigated, IND is applied in USFDA.It is after preclinical study.In preclinical study drug is tested in Animals.

NDA : New Drug Application
When drug is Tested in humans during clinical trial,and recognized as safe and effective,NDA is applied for Marketing in US.

ANDA: Abbreviated New Drug Application
It is application for the entry of Generics in US market.

Generic : It is copy version of Innovator having bioequivelence to innovator.

1 comment:


  1. Great information. I really liked it. Keep updating new information.

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