Orphan drugs benefits from development

BENEFITS OF ORPHAN DRUGS FROM A DEVELOPMENT PERSPECTIVE... 

Benefits of orphan drugs from a development perspective... 

Within the Act itself, the four major benefits are (1) the period of marketing exclusivity, which may be considered as a type of patent (2) the tax benefits on clinical trials between the date of orphan drug designation and NDA approval and (3) the FDA s Office of Orphan Products Development grants to support clinical trials on orphan drugs. A fourth benefit of protocol assistance, from the FDA, was always available for important new drugs (as well as others) and is important, but not necessarily new. Nonetheless, it is useful to call attention to this provision. 

Benefits of Orphan Drugs from a Development Perspective... 

---