Inhalation Drug Delivery Videos
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Patient Adoption Of On-Body Delivery Systems
5/23/2025
In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, panelists Carolyn Dorgan and Courtney Evans from delivery device consultancy Suttons Creek talk with host Fran DeGrazio about factors creating challenges and opportunities in moving patients to on-body injectors (OBIs) and other wearable drug delivery systems.
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Drug Delivery Self-Administration: The Rise Of The Epinephrine Autoinjector
5/23/2025
In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, Courtney Evans, principal consultant at Suttons Creek, comments on drug delivery technology advancements, particularly around the challenge of greater reliability. Her commentary begins with the market introduction of epinephrine autoinjectors and moves to more recent advances in nasal spray alternatives.
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Dry Powder Inhaler Services
We offer comprehensive solutions for Dry Powder Inhalers (DPIs), encompassing all stages from initial formulation screening to clinical-scale manufacturing.
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Combination Products Regulatory Considerations with FDA's Barr Weiner
10/1/2024
From his roles and experiences in the combination products and combined use systems arena, John “Barr” Weiner offers perspectives on how to approach pre- and post-market activities with regulatory requirements and guidance in mind. Cross-functional coordination, integrated development, and primary mode of action (PMOA) designations are among the considerations Barr reminds organizations to implement thoughtfully as they work to advance combination products within a regulatory landscape.
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The Role of ISO 13485 in the New QMSR
7/11/2024
What does the addition of ISO 13485 as reference in the new QMSR mean for those working to comply with 21 CFR 820? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Laurie Auerbach of Compliance Prodigies explains the relationship between the two guidance documents.
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Risk Management and the New QMSR
7/11/2024
What changes in approaches to risk management will the addition of ISO 14385 trigger? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Ed Bills of Edwin Bills Consultant discusses when and how organizations will now need to address risk management within the context of design development and controls.
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Defining and Regulating Combination Products: An Evolutionary Journey
10/15/2024
In this episode of The Combination Products Handbook: The Series, 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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Intranasal Delivery for Post-Viral Smell Loss with Cyrano Therapeutics' Rick Geoffrion
10/29/2024
COVID-19 and other viruses have drawn increased attention to the debilitating effects and potentially consequential underlying causes of hyposmia or anosmia (reduced or complete inability to smell). In this episode of Sit and Deliver, Rick Geoffrion, founder and CEO of regenerative medicine company Cyrano Therapeutics, talks with Sit and Deliver host Tom von Gunden about why an effective therapeutic response may well involve – you guessed it – a payload through the nose.
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Understanding The Global Regulatory Landscape For Combination Products
8/14/2025
In this videocast episode, host Tom von Gunden discusses Chapter 14 of The Combination Products Handbook (CRC Press) with the book’s editor Susan Neadle, along with chapter coauthors Stephanie Goebel, Cherry Malonzo Marty, and Viky Verna. The group provides overviews of the commonalities and variances in regulatory definitions and guidances for combination products across global jurisdictions and agencies.
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How To Identify And Differentiate Combination Products
11/18/2024
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 2 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor and Chapter 2 author, Susan Neadle. Considering both product development and the global regulatory landscape, the discussion focuses on answers to the question posed by the chapter title, “What Is a Combination Product?”