White Paper: Orphan Drugs
Published March 2021
Abstract:
Orphan drugs are drugs intended to treat either a rare disease or conditions that are not developed by the pharmaceutical industry for economic reasons. There are approximately 7,000 orphan diseases affecting an estimated 25 to 30 million people in the United States.
Topics covered in this white paper are:
- Orphan Drugs
- Global Legal Framework
- Comparison of Regulatory Application Requirements
- Comparison of Development Incentives
- Orphan Drugs FAQs
Keywords: orphan drugs, incentives, rare diseases, cGMP API manufacturing, sterile products, Artesunate, FDA, HAS, TGA, PMFA, EMA, Health Canada, market exclusivity, priority review, OOPD, GARD
Click here to view White paper: Orphan Drugs