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.
Breakthrough status means the companies will have closer communication with top FDA staff to move drugs for serious diseases to market more quickly, potentially with data from an expanded Phase 1 trial, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said yesterday. Improved understanding of diseases is leading to more candidates for this status.
“We expect many of these would come available very quickly with Phase 1 data,” Woodcock said.
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