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Browse Sami, Tamra 1-8 out of 8 article(s) Title Type Date Words FDA beefs up criminal enforcement with help from states' attorneys. May 1, 2004 973 Pharmaceutical Inspectorate will follow 'team biologics' model, create PAT team: Web-based investigator training offered. Feb 1, 2004 904 Firms advised to find 'root cause' of GMP faults, get feedback during FDA inspections. Dec 1, 2003 927 FDA to pilot dispute resolution, giving 10 days to challenge 483s. Oct 1, 2003 1265 European sterile drug Annex 1 in effect, but firms, inspectors worried. Sep 1, 2003 1369 Compliance strategies, business drivers must mesh to realize success of FDA GMP initiative. Aug 1, 2003 1218 FDA 'team' inspections should be tied to drug quality, compliance. Jul 1, 2003 1166 Manufacturers want to see FDA eliminate GMP pre-approval inspections. May 1, 2003 910

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