Home » New Quality Office Needed to Link Preapproval Work to GMPs, FDA Officials Say
New Quality Office Needed to Link Preapproval Work to GMPs, FDA Officials Say
September 12, 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.
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