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Regulatory Focus: Update on FDA regulation of ophthalmic combination products

January 31, 2023

Olu Aloba, PhD, Vice President, CMC Services
Marianthi Karakatsani, PhD, Director, Regulatory Affairs CMC
Laura Kilgore, RAC, Vice President, Regulatory Affairs, CMC

Ophthalmic products are regulated under quality standards published in the Code of Federal Regulations (CFR), United States Pharmacopeia (USP), and various US Food and Drug Administration (FDA) guidance. Application of these standards has recently been affected by the legal requirement for the FDA to standardize the regulatory approach to ophthalmic products whose components are considered devices. The agency communicated the update through a guidance outlining the phase-in of the new regulatory requirements and their application to different product types. This article discusses the quality standards for ophthalmic combination products and evaluates their application to marketed and developmental products within the framework of recent regulatory requirements.


Ophthalmology, the diagnosis and treatment of diseases and disorders of the eye, has been documented since ancient times. For centuries, the importance of and fascination with the eye has led to significant advancements in the field. This is no less true today, with a growing interest in the research and development of ophthalmic products. Development of ophthalmic products must take into consideration new regulatory requirements articulated through FDA guidance. Through review of the requirements, as well as selected example applications presented as case studies, the authors will illustrate the application of these new requirements to ophthalmic combination products in different scenarios.

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Regulatory Focus, January 2023. © Regulatory Affairs Professionals Society