Inhalation Sciences presents at well-received FDA public workshop GDUFA
On 20 May Inhalation Sciences AB CSO Per Gerde presented the company’s predictive tools for developing and assessing generic inhaled pharmaceuticals at the FDA’s public GDUFA (Generic Drug User Fee Amendments) webinar (as previously communicated on April 10, 2024). The webinar was well-attended and well-received by a large audience of specialist industry professionals.
ISAB’s webinar session at the workshop was titled “Predictive Tools for Generic Product Development & Assessment”. It was held by ISAB CSO and Founder Per Gerde and ISAB’s Director of Projects Dr Maria Malmlöf.
Engagement in the session was high - the annual GDUFA workshops are open and audience members can provide prepared or impromptu comments.
ISAB’s presentation included the company’s unique platform technology PreciseInhale®, ISAB’s in vitro tool for evaluating the dissolution and absorption of aerosols, DissolvIt®, and also Isolated Perfused Lung (IPL), a specially tailored version of the system designed specifically for aerosols generated by the company’s PreciseInhale® aerosol generation R&D system.
ISAB CEO Manoush Masarrat: “this was a great meeting where we had the pleasure to present and interact with an expert and venerable audience of fellow inhalation scientists. We are pleased to have been invited and we would like to thank the FDA and everyone who took part”.
Read more about DissolvIt®
Read ISAB’s publications on DissolvIt® here.
Read about DissolvIt’s in vitro capabilities here.
Read more about IPL
Read more about IPL here.
