FDA to combine all of its quality ops under a new ‘super’ office

By Zachary Brennan

- Last updated on GMT

New super office will combine a number of different facets.
New super office will combine a number of different facets.

Related tags Food and drug administration

By early next year the US FDA is set to launch a new “super” office known as OPQ (Office of Pharmaceutical Quality), which will better align the review, inspection, and research of drugs.

Originally announced in 2012 in response to a growing focus on generic drug quality, the new office will combine all non-enforcement-related drug quality work to improve the agency’s oversight of quality.

The shift to one “super” office will require a number of changes. Among the expected realignments include:

  • Moving functions and personnel from the Office of Pharmaceutical Science, which oversees the chemistry, manufacturing, and controls (CMC) submissions for drugs and biologics, to OPQ;
  • Shifting preapproval and surveillance inspection activities from the Office of Compliance to OPQ; and
  • Transferring inspection-related activities for bioequivalence/bioavailability and non-clinical studies from OC’s Office of Scientific Investigations to the Office of Translational Sciences.

OPQ creates a uniform drug quality program across all sites of manufacture, whether domestic or foreign, and across all drug product areas​,” the agency says on the new website​.

Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), will lead the new office.

According to a memo obtained by RAPS​ last week, Woodcock said: “The organizational structure, along with new processes and policies, will support our mission to ensure that safe, effective, high quality drugs are available for the American public​.”

Other new offices to be combined under OPQ include ones for Program and Regulatory Operations, Policy for Pharmaceutical Quality, and Process and Facilities.

"This office will provide internal customers with a single drug quality assessment that captures the overall OPQ recommendation on approvability, and OPQ will provide feedback on quality deficiencies earlier in the review cycle​,” she added.

Other leaders that will join OPQ include:

  • 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); and
  • Office of Surveillance (OS): Theresa Mullin (Acting).

The agency did not respond to a request for comment by press time.

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