What is the Role of the Quality Overall Summary (QOS) in BLA and NDA applications?
Author: Suzanne Broussard, PhD The Food and Drug Administration (FDA) is promoting the Quality Overall Summary (QOS) as a powerful tool to promote effective communication between regulators and sponsors of drugs as well […]
Manufacturing and Immunogenicity are Key Considerations for Approval of Biological Products: BLA vs NDA
Author: Suzanne Broussard, PhD Biological products warrant special regulatory consideration because of their complex nature and susceptibility to variation during manufacturing. Biologics are not only complex in their physical structure, they are produced from living […]
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 […]
