Rare Disease Drug Development Course

This certificate course will introduce you to what regulators look for when drugs for rare diseases are submitted for approval. The course covers the most effective routes for drug development in rare diseases. You will learn about the FDA approaches to the challenging aspects of drug development in the rare disease space with examples of rare drug development. You will also learn about expedited programs for drugs that address the serious and life-threatening aspects of rare diseases. You will discover priority review vouchers and how they applies to rare diseases.