What is the difference between NDA and BLA

Differences Between New Drug Application (NDA) and Biological License Application (BLA) The New Drug Application (NDA) and the Biological License Application (BLA) are two critical submissions to the U.S. Food and Drug Administration (FDA), but they cater to different...

Drug Master File & its Types

Drug Master File In this article, we are going to learn about DMF and types of drug master files etc. By the end of this article you are going to the requirement of DMF in regulatory submission i.e. its purpose and also the contents of each drug master file Always...

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