Transdermal Drug Delivery Videos
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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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Partnership And Clinical Trial Strategies For Digitally Connected Devices
5/23/2025
In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, and Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, discuss key product development considerations when bringing digital connectivity solutions to drug delivery devices. These aspects include product and health authority partnerships, clinical studies, and regulatory approvals.
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What Happened to CAPA (Corrective and Preventive Actions) Requirements?
7/11/2024
Is CAPA still part of the requirements picture for the new QMSR? 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 changes in the treatment of corrective and preventive actions.
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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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Leveraging Combination Products For Biologics Delivery
7/22/2025
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 12 on biologics delivery with chapter author Manfred Maeder and the book’s editor, Susan Neadle. Manfred and Susan comment on the challenges of moving large molecule formulations into combination products while considering product stability, usability, and supply chain.
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Developing Regulatory Strategies For Combination Products
12/16/2024
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 3 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor Susan Neadle. The conversation focuses on building into product development a regulatory strategy that incorporates key enablers of market success from early clinical studies, through the marketing application, to post-market changes.
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Leveraging Nanoparticles For High Drug Load Delivery With Nanoform's Christian Jones
7/28/2025
In this episode of Supplier Horizons, host Tom von Gunden talks with Chief Commercial Officer Christian Jones of nanoparticle technology developer Nanoform about innovation in drug and biologics delivery. The discussion covers aspects of patient centricity such as aging populations, in-home self-administration, and personalized medicine. It also focuses on the use of nanotechnology in the delivery of high concentration formulations via oral and subcutaneous routes of administration.
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Understanding Supplier Quality And Controls For Combination Products
5/12/2025
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 10 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor, Susan Neadle, and chapter co-author Fran DeGrazio. On the topic of supplier quality and controls, Susan and Fran discuss key considerations for using third-party suppliers of raw materials, constituent parts, and services in combination product development.
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Confirming EDDOs Based on "Device Dependence"
10/9/2024
Among the characteristics of a device design feature that helps identify it as an Essential Drug Delivery Output (EDDO) is “device dependent.” In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC explains the differences between the concepts of device-dependent versus device-independent and illustrates why only the former is applicable to an EDDO.
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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.