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FDA’s OPQ Chief Tells Generic Drug Makers Its Time To Up Their Quality Game

 
• By Joanne S. Eglovitch

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.

FDA entrance sign 2016
The Office of Pharmaceutical Quality is about to celebrate five-year anniversary. • Source: Shutterstock

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.

During his presentation to the Association for Accessible Medicines GRx-Biosims conference in Bethesda, Md, on 5 November, Kopcha also shed...

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