FDA Plans New Super Office for Quality for January 2015

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 10-22-2014 06:50


The US Food and Drug Administration (FDA)is planning to open the Office of Pharmaceutical Quality (OPQ),a new office within the FDA's Center for Drug Evaluation and Research (CDER) that creates a single unit dedicated to product quality in January 2015. The new structure, to be stood-up in January 2015, is expected to provide better alignment among all drug quality functions at CDER, including review, inspection, and research.

FDA says that OPQ will combine non-enforcement-related drug quality work into one super office, "creating one quality voice and improving our oversight of quality throughout the lifecycle of a drug product. OPQwill create a uniform drug quality program across all sites of manufacture, whether domestic or foreign, and across all drug product areas: new drugs, generic drugs, and over-the-counter drugs."

The FDA says that this organizational structure, along with new processes and policies, will support the agency's mission to ensure that safe, effective, high quality drugs are available for the American public.

Changes include:

CDER Director Janet Woodcock will begin serving as acting director of the OPQ in January, 2015, and Lawrence Yu, acting director of the Office of Pharmaceutical Science, will serve as the deputy director of the OPQ. In addition, the following individuals will begin serving, effective January 2015:  

  • Office of Program and Regulatory Operations (OPRO): Giuseppe Randazzo (Acting)
  • Office of Policy for Pharmaceutical Quality (OPPQ): Ashley Boam (Acting)
  • Office of Biotechnology Products (OBP): Director: Steve Kozlowski
  • Office of New Drug Products (ONDP): Sarah Pope Miksinski (Acting)
  • Office of Lifecycle Drug Products (OLDP): Susan Rosencrance (Acting)
  • Office of Testing and Research (OTR): Lucinda (Cindy) Buhse (Acting)
  • Office of Process and Facilities (OPF): Christine Moore (Acting)
  • Office of Surveillance (OS): Theresa Mullin (Acting)

Source: FDA



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