The director of the US Food and Drug Administration’s drug quality office, Michael Kopcha, said that a reorganization within the Office of Pharmaceutical Quality reflects an even-more targeted focus on drug quality, and urged the generic drug industry to take a similarly focused approach in addressing manufacturing quality.
FDA’s OPQ Chief Tells Generic Drug Makers Its Time To Up Their Quality Game
The head of US FDA’s drug quality office comments on quality-related topics at the GRx-Biosims meeting; sheds more light on facility rating system plan.
