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Home » Quality Office to Link Preapproval Work, GMPs, Handle Generic Hurdles
Quality Office to Link Preapproval Work, GMPs, Handle Generic Hurdles
September 25, 2012
BALTIMORE — CDER’s proposed new Office of Pharmaceutical Quality (OPQ) is needed to promote good manufacturing practice (GMP) standards in the preapproval setting — standardizing GMP assessments throughout a drug’s life cycle.