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- Operational talent, not just science, will drive next biopharma breakthroughsThe piece points out that while breakthrough science, founders and venture funding are typical markers of progress, the real test is moving a promising therapy through GMP production, quality syste…
- FDA offers guidance for smoother BLA submissions and outlines biosimilar review changesSubmitting a biologics license application requires early interaction with the FDA's Office of Therapeutic Products, careful preparation to avoid technical and administrative mistakes, and keeping…