An Introduction to IPAC-RS

After the U.S. Food and Drug Administration released its 1998 draft guidance on metered dose inhalers and dry powder drug products, a group of developers, manufacturers, and marketers of orally inhaled and nasal drug products (OINDP) joined together to provide a response. This ad hoc group developed a consensus response to the proposed guidance in 1999. After two years of collaborative OINDP industry efforts to address concerns with the state of regulatory guidance, changes in the regulatory environment, as well as the global focus of the Consortium’s member companies, led to a broader scope of activities. In order to fully address their needs, the ad hoc group formed an industry association, the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS).