Sec. 5. Food and Drug Administration cavernous angioma clinical trial preparedness and support program
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/bill/113/s/1223/is/section-5A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The Commissioner of Food and Drugs shall work with clinical centers, investigators, and advocates to support appropriate investigational new drug application under section 505(i) of the Federal Food, Drug, and Cosmetic Act in an effort to hasten the pace of clinical trials for cavernous angioma. Where applicable in rare subpopulations of cavernous angioma requiring unique pharmacological intervention, including those 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.