Drugs

Spotlight on CDER Science

Spotlight on CDER Science

Novel Approach Allows Expansion of Indication for Cystic Fibrosis Drug

Tony Durmowicz, M.D., Lead Medical Officer, Division of Pulmonary, Allergy and Rheumatology Products, Office of Drug Evaluation II, CDER
Mike Pacanowski, Pharm.D., MPH, Associate Director for Genomics and Targeted Therapy, Office of Translational Sciences, CDER

Typically, when FDA approves an expansion of the indication for a drug, it means that additional clinical data have shown the drug can safely and effectively treat patient populations other than those for which it was originally intended. But collecting additional clinical data is sometimes very difficult, especially with rare diseases. Patient populations are small and are often scattered throughout the country or the world, and therefore hard to access.

More with Tony Durmowicz, M.D. and
Mike Pacanowski, Pharm.D., MPH

Page Last Updated: 05/17/2017
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