FDA To 'Radically' Overhaul Drug Industry Quality Policies

MIAMI -- Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), announced Wednesday (Feb. 11) that the agency is planning to “radically change” its approach to quality enforcement with regards to generic and brand drug manufacturers in order to foster a culture of quality within the industry. Speaking at the Generic Pharmaceutical Association's (GPhA) annual conference in Miami, Woodcock said rather than just issuing citations for quality infractions FDA will give companies quality “report cards” following inspections,...

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