Human Factors Discussion - Summary

Thank you to Bjorg Hunter (GSK) and her industry colleagues for providing the summary of discussions that occurred during the Xavier Combination Products Summit September 12-14, 2018 related to Human Factors (HF) Protocol submission in line with the draft regulatory guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development, section IV.C.  After the summit, a group of industry and FDA members continued the discussion on additional topics, which is summarized within the document as well.

Feel free to forward the document to all those you think would find it valuable, and thank you for helping us Make a Difference in the lives of the patients you serve!

2019 Xavier Combination Products Summit

Don’t forget to join us for the 2019 Xavier Combination Products Summit coming very soon: September 11-13, 2019 with a workshop and Office Hours with FDA’s Thinh Nguyen and Barr Weiner occurring on the 11th.