Workshop: Essential Drug Delivery Output

Wednesday, November 12, 2025

3:15 PM - 5:15 PM East Coast USA Time

Moderator(s)

Ryan McGowan

Director, Digital Devices and Combination Products
AstraZeneca
Andrea Redd

Associate Vice President, Global Regulatory Affairs, Drug Delivery and Combination Products
Eli Lilly

Speaker(s)

Kristin Benokraitis

Executive Director, Device Quality & Regulatory
Merck
Fran DeGrazio

President & Principal Consultant
Strategic Parenteral Solutions
John McMichael

Director, CMC Regulatory Affairs, Devices & Digital Therapeutics
AstraZeneca
Susan Neadle (she/her/hers)

Principal Consultant & President
Combination Products Consulting Services, LLC, Florida, United States
Suzette Roan

Associate Vice President, Head of GRA Devices
Sanofi

In June 2024 the FDA released a draft guidance on Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. The draft guidance describes Agency expectations for essential drug delivery characteristics for certain medical devices and combination products and articulates an approach to identify and submit this information for FDA review. This session seeks to better understand how industry has interpreted key concepts in the guidance and explore how these concepts can be integrated into existing clinical and commercial development process as well as global regulatory submissions.
This will workshop will include exploration of central aspects of the draft guidance; unpacking key EDDO Concepts; Envisioning the Future of EDDOs

Feedback from this workshop will be used to generate a discussion paper on key messages that can serve as a resource guide for stakeholders as well as for future discussions with the FDA.