In USA, the term “Orphan drug” has two definitions. The first describes drugs or biologics that are used for the prevention, diagnosis, or treatment of diseases or conditions affecting fewer than 200,000 persons in the US. The second definition describes a drug or biologic that is intended for diseases or conditions affecting 200,000 or more people, or for a vaccine, diagnostic drug, or preventive drug to be administered to 200,000 or more persons per year, where the drug will not be profitable within 7 years following FDA approval.
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.
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