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Home » Office of Pharmaceutical Quality Revs Up Process to Accelerate U.S. ANDA Reviews
Office of Pharmaceutical Quality Revs Up Process to Accelerate U.S. ANDA Reviews
In a preview of how the U.S. Food and Drug Administration’s new Office of Pharmaceutical Quality will speed generic drug approvals, the office is rolling out a framework for filers of abbreviated new drug applications to respond to minor queries regarding chemistry, manufacturing and control early in the review cycle.
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