Janet Woodcock, FDA's Chief Medical Officer, on PAT, QbD and the Critical Path
In her plenary speech, Dr. Janet Woodcock, Chief Medical Officer and Deputy Commissioner of FDA, affirmed the Agency's support for PAT, from the Commissioner level down, but tied its goals to those of Quality by Design, and the Critical Path.
In her plenary speech at IFPAC `07, FDA's Deputy Commissioner discussed the importance of PAT to the Agency's current objectives, not only Quality by Design, but the Critical Path. She stressed the need for science-based approaches for both drug development and manufacuring, and outlined some of the challenges applying these concepts to the clinical area. To download an audio tape of her speech, click here. To read a full transcript, click here.