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ANDA

IND, NDA AND ANDA DRUG EVOLUTION PROCESS

The Federal Food, Drug and Cosmetics act regulated through Title 21 of U.S Code of federal Regulations, requires a new drug to be approved by FDA before legally getting introduced into the market. In...

DRUG REGULATORY AFFAIRS AND ITS COMMON TERMINOLOGIES

Regulatory Affairs:- Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration...

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