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Innovative Drugs May Win U.S. Approval After Early Trials

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 them to patients, a Food and Drug Administration official said.

The agency assigned three experimental medicines the new status to try to reduce the time needed to get them to market against deadly diseases, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said yesterday in an interview before a Bloomberg health conference in New York. Vertex Pharmaceuticals Inc. said last month that two of its drugs for cystic fibrosis had won the designation.