- Author(s):
- Organization(s):
Lostritto Consulting
In this opinion article, the author suggests that, supported by multiple precedents, a propellant for a pressurized metered dose inhaler (pMDI) may be feasibly regulated as a device component in these drug-device combination products. Furthermore, this new paradigm may apply particularly well when an applicant for an approved pMDI combination product provides a submission to switch the propellant to a low global warming propellant (LGWP, 3GP) via the prior approval supplement (PAS) pathway.
The author explains that in the FDA combination product review model for pMDIs, the Center for Drug Evaluation and Research (CDER) could continue to lead the pMDI review, and the Center for Devices and Radiological Health (CDRH) could review, from an engineering perspective, the propellants’ physical aerosolization function. He also discusses the theoretical basis for the recommendation, the practicality of the theory, the value in treating pMDI propellants as device components, technical considerations and regulatory engineering a propellant-PAS approach for approved pMDIs.
December 2025, Volume 19(6), pages 25-31