Let’s Modernize Manufacturing
The FDA’s Janet Woodcock says that manufacturing will change in the coming years. How? The answer lies in the hands of industry
Stephanie Sutton |
Current pharmaceutical manufacturing approaches are not without issue – and someone who knows of the problems all too well is Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research. After all, as she puts it, regulators such as the FDA are the ones dealing with the consequences all of the time.
Woodcock spoke at the recent International Symposium on Continuous Manufacturing (ISCMP), held in London, offering the FDA’s perspective on the need to modernize the manufacture of pharmaceuticals. “Technology has transformed to allow continuous processes to exist and they have existed for a long time. Traditionally, the perception of risk, including regulatory risk, initial investment and the sub-costs has limited uptake,” said Woodcock. “Evolution in science and technology will drive the need for new methods. The technology available has been used in other sectors and the regulators are on board.”
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