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Home » PDUFA Bills Appear to Authorize FDA to Require Supplier Quality Accords: Expert
PDUFA Bills Appear to Authorize FDA to Require Supplier Quality Accords: Expert
June 8, 2012
BALTIMORE — Proposed language redefining current good manufacturing practices (cGMP) included in both versions of omnibus FDA user fee legislation appears to give the agency new authority to require drugmakers to make supplier quality agreements, a compliance expert says.