Sec. 5. Food and Drug Administration cerebral cavernous malformations clinical trial preparedness and support program

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The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall coordinate with clinical centers, investigators, and advocates to support appropriate investigational new drug applications under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ) in an effort to hasten the pace of clinical trials for cerebral cavernous malformation. Where applicable in rare subpopulations of cerebral cavernous malformation requiring unique pharmacological intervention, including subpopulations with the common Hispanic mutation or CCM3 gene mutations, the Commissioner of Food and Drugs shall support appropriate requests for designations of drugs as orphan drugs under section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb ).

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Sec. 5

Food and Drug Administration cerebral cavernous malformations clinical trial preparedness and support program

U.S.C.§ 355

U.S.C.§ 360bb

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