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 | Jun 25, 2024
An abbreviated new drug application is submitted to the FDA Office of Generic Drugs. let us learn about generic drug products before the ANDA application Process. A Generic drug product is comparable to the innovator in terms of strength, dosage form, route of...
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...
