Common Problems to Avoid with IND Applications for New Drugs and Biologics
Author: Suzanne Broussard, PhD One of the first steps toward obtaining approval to market drug products or biological compounds in the United States is the submission of an Investigational New Drug (IND) application. Your research team is hard at work developing a very promising new drug, and they are naturally anxious to get a product to […]
What Are the Major Regulatory Differences for Getting a Biologic Product Versus a Drug Compound into The Marketplace? BLA vs NDA
Author: Suzanne Broussard, PhD The unique characteristics and manufacturing processes of therapeutic biological products and drug compounds lays the framework for the differences in regulatory requirements for getting into the […]
