Case Study
Patient-centric Approach to Clinical Trial Support Leveraging Medical Information Services
The FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) approve dozens of new therapies each year, averaging 38 novel drugs and 16 biologics annually. While many approvals come from established pharmaceutical companies with existing commercial infrastructure, a growing share originates from emerging biopharma organizations launching their first product. In 2022, CDER and CBER approved 51 new products, including 37 drugs and 14 biologics, with approximately 30% coming from first-time launch companies. This trend highlights both the opportunities and challenges facing emerging biopharma firms as they transition from development to commercialization, requiring strong medical affairs, operational readiness, and strategic planning to succ
