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By Drug Delivery Leader: The Combination Products Handbook: The Series | In this initial episode, host Tom von Gunden discusses the book’s intent with its editor, Susan Neadle. The discussion focuses on the rationale for each chapter and the expert contributions of various chapter authors and co-authors. |
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Defining And Regulating Combination Products: An Evolutionary Journey | By Drug Delivery Leader: The Combination Products Handbook: The Series | Here, host Tom von Gunden discusses Chapter 1 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023) with the book’s editor, Susan Neadle. Given that the initial chapter was penned by the FDA’s John “Barr” Weiner, the discussion focuses on reasons for establishing the historical and regulatory context for combination products early in the handbook’s topic coverage. |
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| Revised EU Annex 1: Shaping The Future Of Drug Delivery | Article | By Jaime Rain, Kymanox Corporation | The revisions to EU Annex 1 set the stage for the future direction of the pharma/biotech industry. Explore some of the key takeaways and interesting changes for risk management and contamination control. |
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