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Be Patient, Says Winkle: PAT Standards Development Will Take Time

By Helen Winkle, Director, Office of Pharmaceuticals, FDA/CDER

PharmaManufacturing.com

In her remarks to the ASTM Committee E55 Workshop on Application of PAT to the Pharmaceutical Industry, FDA's Helen Winkle, director of CDER's Office of Pharmaceuticals, noted that the Agency's cGMP Initiative for the 21st Century dictates the need for developing and supporting standards for PAT. However, she also said standards development may be a rocky road and realistically, once developed, standards will take time to implement.

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