Learning Tracks

This workshop will explore new opportunities and approaches for directly engaging industry experts in the GDUFA research program. Participants will discuss potential mechanisms for industry experts to inform the assessment of research projects, and to collaborate on the conduct of research activities. The workshop will also solicit generic drug industry input to inform FDA’s prioritization and development of product-specific guidances (PSGs). Discussions will also address what scientific and procedural details would make PSG recommendations clearer and more actionable, including recommended tests and studies, study-design considerations, analytical methods, and approaches for conducting and interpreting relevant assessments. A distinguishing feature of this year’s workshop will be structured small-group discussions that allow participants to engage directly with FDA, provide candid feedback, and develop practical recommendations for enhancing the GDUFA Research Program.