Scientific Publications by FDA Staff

J Am Pharm Assoc 2016 Mar-Apr;56(2):201-2

Food and Drug Administration: helping pharmacists ensure that patients receive high-quality medicines.

Kremzner M

OBJECTIVES: 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). SUMMARY: 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. CONCLUSION: 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.