Ocular Drug Delivery Videos

  1. Applying Control Strategies to EDDOs 10/9/2024

    After Essential Drug Delivery Outputs (EDDOs) have been identified, each will need to be controlled during the development of a drug delivery device.  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 provides the rationale for a risk-based approach to EDDO control strategies.

  2. Preconditioning Devices under EDDO Guidance 10/9/2024

    What does the FDA’s guidance on Essential Drug Delivery Outputs (EDDOs) mean for activities involved in preconditioning the device delivery components of combination products? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens,  regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, discusses the likely intent and impact of EDDOs on preconditioning for both manufacturers and sponsor companies.

  3. 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.

  4. Understanding the Difference Between EDDOs and Primary Functions 10/9/2024

    How do Essential Drug Delivery Outputs (EDDOs) differ from Primary Functions – for example, as described in ISO 11608 regarding needle-based injection systems? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens,  regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, describes the differences between the two concepts, including how they differently relate to considerations of risk.

  5. Clarifying The EDDO Focus On Design Outputs, Not Design Inputs 10/9/2024

    In what ways are Essential Drug Delivery Outputs (EDDOs) different from design inputs for combination products? 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 difference.

  6. Understanding The Change From EPR To EDDO 10/9/2024

    Why does the FDA’s new guidance on drug-led or biologic-led device design include a change in terminology from Essential Performance Requirements (EPRs) to Essential Drug Delivery Outputs (EDDOs)?  In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens,  regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, offers his perspective on how the change in terminology clarifies key concepts related to design controls.

  7. Identifying EDDOs During Drug Delivery Device Design 10/9/2024

    How are EDDOs (Essential Drug Delivery Outputs) determined during the design of a drug-led or biologic-led combination product? 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 lays out the foundational considerations.

  8. 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.

  9. Improve The Performance Of Your Small And Large Molecule Medicines 7/23/2024

    Explore the latest in nanotechnology advancements including recent clinical data, formulation applications, and API optimization to NanoImprove formulations.

  10. What Is the Impact of the New QMSR on 21 CFR Part 4? 7/11/2024

    In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio enlists consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to summarize where Part 4 is documented in the new guidance.