by Naveen kumar | Sep 29, 2024
“Essential Regulatory Affairs Interview Questions for Freshers in Pharma: Tips & Answers” 1. What is an Abbreviated New Drug Application (ANDA)? Answer: An Abbreviated New Drug Application (ANDA) is a regulatory submission to gain approval for a...
by Naveen kumar | Sep 14, 2024
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...
by Naveen kumar | May 6, 2024
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...
