Creating a Roadmap for NDA Success: Key Steps and Considerations
The New Drug Application (NDA) submission process is a pivotal phase in the lifecycle of a drug, marking its transition from a promising compound in clinical trials to a marketable […]
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 […]
