As physicians struggle to understand FDA’s approval standards . . .

Woodcock Says Drug Development Paradigm Needs To Change, But Not At FDA

/ April 12, 2016 at 5:59 PM
FDA drug center chief Janet Woodcock told congressional staffers and patient stakeholders that the way to further streamline development of breakthrough oncology drugs is to launch trials that investigate multiple drug options and combinations at once. Her comments come as a recent survey shows many physicians misinterpret the term breakthrough to mean these drugs were supported by stronger evidence than required by the statute. Woodcock additionally said that newer technology, such as continuous manufacturing, will likely be the future for...

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