title: Food and Drug Administration: Helping pharmacists ensure that patients receive high-quality medicines.
abstract: OBJECTIVE
  Ensuring that the drugs patients take are safe and effective is critical to the Food and Drug Administration (FDA) mission and a major reason for testing an active pharmaceutical ingredient or currently marketed drug product. To address gaps in the assessment of drug quality, FDA's Center for Drug Evaluation and Research (CDER) has created the Office of Pharmaceutical Quality (OPQ).
  
  
  CONCLUSIONS
  This newly formed "super-office" within CDER launched a concerted new strategy that enhances the surveillance of drug manufacturing and will bring a comprehensive approach to quality oversight.
  
  
  CONCLUSIONS
  With OPQ and these new performance measures in place, FDA can sharpen its focus on issues critical to quality and can identify and respond to manufacturing issues before they become major systemic problems.
authors.forename: Mary
authors.initials: M
authors.lastname: Kremzner
mesh_terms: D006801:Humans; D000072499:Manufacturing and Industrial Facilities / Q000592:standards; D061214:Patient Safety; D004364:Pharmaceutical Preparations / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*
chemical_list: D004364:Pharmaceutical Preparations