The annual GDUFA Public Workshop is open and free to the public, and any member of the public may provide comments to the docket for the meeting or may provide their public comments in a prepared presentation, or as impromptu comments. The FDA routinely announces the workshop and provides information about how the public may provide comments. This includes information about how the public can submit a request to provide a public comments presentation.

The topic of the session is "Predictive Tools for Generic Product Development & Assessment" and ISAB's presentation will be held by the company's founder and Chief Scientific Officer Per Gerde.

ISAB CEO Manoush Masarrat: "We are very pleased to be invited by the FDA and we really look forward to discussing the challenges for generic product development and assessment! ISAB is increasingly gaining a reputation as a leading innovator and provider of Inhalation Research Services, offering a broad range of services within this field".