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An Evolving Regulatory Landscape: U.S. Food and Drug Administration’s Evidence-Based Perspectives on Next Generation Propellant Transitions

Newman B, Luke M.

Respiratory Drug Delivery 2026. Volume 1, 2026: 21-0.

Abstract:

The phase-down and transition from current hydrofluoroalkane (HFA)-based propellants to next generation propellants (NGPs) remains an ongoing and complex process, affecting metered dose inhaler (MDI) development and ultimately the access and cost of treatment for patients. The U.S. Food and Drug Administration (FDA) is continuing its efforts to streamline this transition through cross-agency collaboration, communication with the industry, and laboratory research to better understand NGP performance effects. This article summarizes some of these efforts, including FDA’s NGP research and potential implications for development programs for brand and generic MDIs considering an NGP product submission.