Addressing Regulatory Challenges For Ophthalmic Combination Products

By Jeffrey Tremain and Ania VanDyke, AbbVie Contract Manufacturing

The regulatory landscape for ophthalmic formulations has shifted significantly, with traditional eye drops now classified as drug-device combination products. This reclassification merges distinct drug and medical device frameworks, exponentially increasing compliance complexity for developers. Navigating this intersection requires identifying the primary mode of action early to determine agency jurisdiction, alongside managing rigorous design controls, verification, and validation phases typically reserved for medical hardware.

Furthermore, developers must establish comprehensive quality management systems that satisfy both pharmaceutical good manufacturing practices and device quality regulations. Successfully managing these dual requirements is vital to preventing costly development delays and ensuring a streamlined path to commercialization. Read the complete insight piece to learn more about navigating these complex regulatory hurdles and executing an optimized submission strategy.