Guest guest Posted April 18, 2003 Report Share Posted April 18, 2003 Palazola wrote: >... may I ask what is Orphan Drug Status? ... > M replies: 'Orphan drug' is the term applied to pharmaceuticals specially developed to combat rare diseases for which there is a significant unmet clinical need. Orphan drug status provides for US marketing exclusivity for seven years upon marketing approval by the FDA. The status also provides certain tax benefits for related clinical development costs, the possibility to apply for clinical research grants, and a potential waiver for marketing application user fees. It also provides for assistance from the FDA to facilitate the development and registration of the product. Quote Link to comment Share on other sites More sharing options...
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