The FDA recognizes biomarker development as a high priority area for future research. BBCR can help your company with your product development plan and validation. BBCR is dedicated to supporting pharmaceutical innovators in the specialized rare diseases and orphan drug indications by developing and nurturing the product’s unique strengths. Our operational mission is to craft […]
The primary difference between a biomarker and a surrogate marker is that a biomarker is a “candidate” surrogate marker. In contrast, a surrogate marker is a test used and taken to measure the effects of a specific treatment. While the current law and regulations permit the FDA to base the approval of a drug product […]
The FDA recognizes biomarker development as a high priority area for future research. BBCR can help your company with your product development plan and validation.