Drug quality concerns spur new U.S. FDA unit

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Posted: Saturday, February 15, 2014 12:00 am

Drug quality concerns, such as those that have banned U.S. sales of generic medicines from several Indian manufacturing plants, have spurred regulators to create a new unit to sharpen their oversight.

The Food and Drug Administration is establishing an Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand-name, generic and over-the-counter drugs, Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, said Friday.

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