Drugmakers may win approval from U.S. regulators for breakthrough therapies after a single round of studies, rather than three, in an effort to speed life-saving medicines to patients. Three experimental medicines have been granted the fast-track designation-including two cystic fibrosis treatments made by Vertex Pharmaceuticals. And 18 additional drugs, many cancer-related, have been submitted, according to Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. In contrast, Woodcock said the agency is taking its time considering whether to approve copies of biotechnology medicines, or so-called biologies.
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