473905 Regulatory Considerations for Introducing New Technologies during Drug Development

Thursday, November 17, 2016: 3:15 PM
Continental 5 (Hilton San Francisco Union Square)
Rapti Madurawe, CDER/OPS/ONDQA, FDA, Silver Spring, MD

This presentation will cover regulatory aspects to consider when introducing new technologies during the development phase, with emphasis on changes made during the latter stage of product development. Some case studies of new technologies will be also be discussed.

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