Pharmaceutical Regulation

A Quick Guide for IND Application

How many types of FDA IND application? There are multiple types of IND application. Generally, your IND will be either 1) commercial or 2) research. It depends on whether it will be used to support marketing application afterwards. There are then three...
Pharmaceutical Regulation

A Quick Guide to FDA pre IND Meeting

What is a pre IND meeting with FDA? Pre IND meeting with FDA is an important step of IND application. An IND application is (a) sponsor(s) that submit the product’s data and information to FDA (Food...