Drug delivery


Solving the EDDO guidance puzzle


A long-awaited draft guidance was released by the FDA in June 2024 that establishes


and defi nes new terminology and seeks to clarify expectations from the agency related to Essential Drug Delivery Output (EDDO) requirements. Abi Millar talks to lawyers Bonnie


Odom and Megan Robertson, from Epstein Becker & Green, about what the EDDO draft guidance entails and how industry has been responding.


D


rug-device combination products are a cornerstone of the pharmaceutical industry. Referring to any product that combines a drug with a medical device – think autoinjectors, nebulisers or infusion pumps – they are typically very effective and user-friendly. Crucially, the drug delivery mechanism is tailor-made for that medicine. And in many cases, patients can ensure they’re getting the appropriate dose, with no need to measure it out. It’s no wonder that sales are surging. Between 2023 and 2033, the global market for drug-device combination products is projected to double from $118bn in 2023 to $236bn,


according to insightSLICE. This growth is being fuelled by a wave of medical innovation, with cutting-edge devices like smart inhalers and wearable patch systems becoming increasingly commonplace. The goal is to make life easier for the patient or clinician. However, that doesn’t mean it’s always smooth sailing for the manufacturer. Compared with standalone medical devices or pharmaceutical products, combination products can present unique regulatory challenges. And while many regulatory agencies have taken pains to ease the burden, the development and approval process can remain hard to navigate.


26


World Pharmaceutical Frontiers / www.worldpharmaceuticals.net


Panya_photo/www.shutterstock.com


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58