CDER restructures for product quality initiative

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, announced that CDER will restructure to implement her plan to modernize drug quality oversight through a "super-office" that will cover all domestic and foreign manufacturing sites and span all drug product areas - new drugs, generics and OTC products.

The move reflects Woodcock's focus on improving oversight "throughout the lifecycle of a drug product" by pushing for modern manufacturing technology and surveillance strategies in a bid to provide safer products that can be made more cost-effectively (see BioCentury, August 4). ...