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Home » New Quality Office Needed to Link Preapprovals, GMPs: FDA Officials
New Quality Office Needed to Link Preapprovals, GMPs: FDA Officials
October 1, 2012
BALTIMORE — CDER is exploring the creation of a new Office of Pharmaceutical Quality (OPQ) that would oversee quality throughout a drug’s lifecycle — partially by promoting GMP standards in the preapproval setting, FDA officials say.