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"Eying The Drug Delivery Regulatory Landscape: 'Must See' Watch List For 2026"

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Chief Editor Tom von Gunden engages drug delivery regulatory experts Rumi Young (Novartis, former FDA), John "Barr" Weiner (Barr Consulting, former FDA), and Fran DeGrazio (Strategic Parenteral Solutions) in a dynamic discussion of the current and near future regulatory landscape for drug and biologics delivery devices, systems, platforms, and combination products. In a “Look Back,” Tom invites the panel to comment on occurrences of note in 2025 that impacted delivery product development and related regulatory pathways. 

In a “Look Forward,” Tom asks each panelist to identify for group discussion a top candidate for the “Most Impactful” regulatory movement or consideration for 2026 and beyond. Panel commentary and audience interaction references specific standards and guidances, such as the QMSR, as well as review progress toward global regulatory harmonization for delivery devices and combination products. 

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