On April 18, the FDA issued a long-awaited revised draft guidance Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) products – Quality Considerations. This draft guidance was previously published on November 13, 1998, and provides recommendations to the orally inhaled and nasal drug product (OINDP) industry on the development and manufacture of MDIs and DPIs and information to be submitted for inclusion in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) collected and submitted comments from its members on the revised draft guidance.
IPAC-RS is a consortium of leading developers and manufacturers of OINDP, and suppliers that seeks to advance the regulatory science of OINDPs through discussion, research, and publication. One of IPAC-RS’s foundational activities was mobilizing the OINDP industry to provide extensive comments to the original 1998 draft guidance, addressing delivered dose uniformity, extractables and leachables, aerodynamic particle size distribution, supplier quality, and quality by design approaches.
Since that time IPAC-RS has evolved into the leading technical organization and advocate for the OINDP industry. It has established effective collaborations with FDA and other regulatory agencies world-wide on a number of scientific, technical and regulatory issues critical to the OINDP industry, creating and publishing on new approaches to key performance tests, analysis and development processes. The newly issued draft guidance, which provides recommendations within a quality by design framework, and references IPAC-RS work on delivered dose uniformity and leachables/extractables, presents new opportunities for IPAC-RS to engage collaboratively with FDA.
IPAC-RS will be planning webinars and other forums addressing technical and regulatory issues relevant to OINDPs and the implications of the revised draft guidance. For more information on IPAC-RS and its activities, please contact Dede Godstrey (firstname.lastname@example.org).