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FDAnews Drug Daily Bulletin
June 6, 2012 | Vol. 9 No. 111
Drugmakers Still Not in Gear on Quality; FDA Considering QbD Incentives, Woodcock Says
Despite recurring pharma quality problems, drugmakers are still inclined to meet minimum manufacturing standards set by regulators, rather than make quality central to their business model. But to help turn the tide, the agency is moving to develop “science-based” incentives for quality efforts with an eye toward scaling back inspections, CDER Director Janet Woodcock said Monday.
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