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Orphan Products

Accelerate development for products intended to diagnose, treat, cure, mitigate or prevent rare diseases

Orphan drug development expertise

Orphan drug and device facts

A disease that affects fewer than 200,000 people in the United States or that affects more than 200,000 people but is not expected to recover the costs of developing and marketing a drug. Orpdan drugs and biologics are developed to diagnose, treat or prevent a rare disease.

An orphan disease in which more than 50% of the affected population in the United States is 0 to 18 years of age.

More than 25 million patients suffer from an orphan disease. The Orphan Drug Act was passed in 1983 to stimulate development of therapies to help these patients.

A medical device that is intended to benefit patients by diagnosing or treating a disease or condition that affects fewer than 4,000 individuals in the United States per year.

Cardinal Health provides consulting services to help companies through the entire orphan drug and device development process, including product analysis, orphan drug designation request, humanitarian use device designation request, regulatory application preparation and post-approval requirements. Our regulatory scientists possess the experience and expertise needed to help you navigate the complex orphan product development and approval processes in compliance with regulatory requirements.

Todd Phillips, PharmD, RAC

Todd Phillips, PharmD, RAC