On 29 June, Timothy Cote, head of the Office of Orphan Products Development at the US Food and Drug Administration (FDA), concisely summed up the agency's policies with respect to the approval of drugs and other medicinal products for rare diseases: "No policy at all."rnThe irony of this assessment is that the United States has long been a leader in stimulating the development of therapies for rare diseases.
展开▼
