FDA is a Public Health Agency whose regulatory mission is supported by the science-based activities of each of its regulatory centers. The Regulatory Science Framework comprised of strategic initiatives, have played important roles in the identification and implementation of analytical technologies to support regulatory science activities. Key objectives of the FDA Regulatory Science Initiative, the FDA Critical Path Initiative and the FDA Quality Initiative are innovation and the efficient implementation of emerging analytical technologies and innovative applications to support regulatory science. Further highlighting the importance of novel analytical technologies, the Office of Pharmaceutical Quality has created the Center for Excellence (COE) for Pharmaceutical Analysis and Characterization. The mission of this COE is to advance the use of modern analytics for complex drug products. This presentation will discuss innovation and the regulatory science framework that has helped to implement modern analytical technologies and innovative applications for pharmaceutical analysis. Case studies will be presented that highlight innovative excellence for the current and next generation of pharmaceutical analysis procedures for regulatory science.<br/>

Innovation and novel applications for pharmaceutical analysis

256th National Meeting (2018)

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