FDA will start the new year with its Office of Quality in place

The FDA's Janet Woodcock said two years ago that the FDA would create a new superoffice focused on drug quality. Regulatory Focus says the Office of Pharmaceutical Quality (OPQ) will finally open Jan. 1, and given that Woodcock has yet to get a director in place for it, she will serve as its first acting director. Quality issues have led to closed plants, recalls and drug shortages, so Woodcock figures that getting the industry more focused on quality can only mean better results for everyone. RF reports that in a letter to her troops, she said among other things that OPQ will establish a "uniform drug quality program" for all drug manufacturing facilities, both domestic and foreign, as well as all product types, new drugs, generic drugs and over-the-counter drugs. With the new office in place, there will be a realignment in CDER as some operations move under its control, RF said. Story | More