Access to Medical Treatment Act Hearing of the Committee On Labor And Human Re

Cover Access to Medical Treatment Act Hearing of the Committee On Labor And Human Re
Access to Medical Treatment Act Hearing of the Committee On Labor And Human Re
United States Congress Senate Committee On Labo
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SUPPORT FOR INNOVATION AND RESEARCH The FDA also is actively engaged in supporting and encouraging innovation and research. In addition to the product specific efforts identified above, the agency is workina to help expand product development by the private sector.
Orphan Products Program The Orphan Drug Act (ODA) of 198 3 and its amendments authorize the agency to provide incentives for the development of drugs and devices to prevent and treat rare diseases. These are principally financial inc
...entives, intended to make products that are commercially marginal more attractive to developers. These financial incentives include clinical research tax credits, grants for clinical research, and exclusive marketing rights once these products have been approved for marketing.
82 FDA's Office of Orphan Products Development works with manufacturers or individual researchers on the development of their products. Activities include administering the orphan designation process, awarding grants to support clinical trials of products to treat rare diseases or conditions, and providing other services in support of products to treat rare diseases.


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