FDA's Woodcock changing up drug quality oversight

Janet Woodcock, the director of the Center for Drug Evaluation and Research (CDER) at the FDA, is shaking things up a bit in her part of the agency. In addition to elevating the Office of Generic Drugs (OGD) to a "super Office" that will oversee other offices, she has turned her attention to quality and manufacturing. In her letter to the troops, posted by PharmaManufacturing, she proposes "other structural changes to sharpen our focus and bolster our resources around pharmaceutical quality. Quality is the underpinning of everything we do, and it is imperative that we have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety." Given the global nature of drug manufacturing, she says the FDA needs systems in place to deal with quality issues before they become problems. How will she do that? While not entirely specific, she says she may create an "Office of Pharmaceutical Quality (OPQ)," to oversee quality throughout the life cycle of a drug. It could take on some responsibilities now handled by the Office of Pharmaceutical Science (OPS). She also might reassign some of the responsibilities in the Office of Manufacturing and Product Quality (OMPQ) in the Office of Compliance into the new OPQ. "As a regulatory agency, we want the public to be confident that we are successfully dealing with the global economy that is constantly adding more players, more technologies, and more complexity," Woodcock says in the letter. Letter | More

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