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Safe and EffectiveThe Medical Human Factors Podcast Author: Human Factors Cast
If you're interested in staying informed about the latest developments in medical human factors and user experience, then Safe and Effective is the podcast for you. We bring you lessons learned, case studies, and regulatory updates, through our conversations with experts from industry, academia, and government to share their insights and experiences with you. Join us as we explore the world of human factors and its impact on the medical field. Whether you're an industry expert or a novice looking to learn more, Safe and Effective, The Medical Human Factors Podcast is for you. Language: en Genres: Health & Fitness, Medicine, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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FDA Regulatory Roundup: CDER Human Factors ANDA Guidance (ft. Melissa Lemke)
Episode 12
Friday, 28 February, 2025
Join us in our latest episode of Safe and Effective, where we take a deep (and possibly exasperated) dive into one of the most debated regulatory guidances in the drug-device combination product world — the FDA’s Comparative Analyses and Comparative Use Human Factors Studies Guidance — with none other than our dear friend, industry powerhouse, and regulatory truth-teller, Melissa Lemke.We’re tackling the big questions head-on: * What does this guidance actually say (versus what people think it says)? * Where does it hit the mark? * And where does it leave us wondering if regulatory agencies and industry are even speaking the same language? From decoding the intent behind comparative use studies to unpacking why the non-inferiority statistical approach is still a regulatory AND a human factors headache, Melissa and Heidi break down the nuances of this guidance — calling out problem areas, highlighting the biggest misconceptions, and, of course, offering a few unsolicited (but definitely necessary) ideas for improvement.Whether you’re a regulatory pro navigating drug-device submissions, a human factors engineer caught in the crossfire of comparative studies, or just here for some unfiltered industry banter, this episode is a front-row seat to the real talk you won’t find in official guidance documents.Expect strong opinions, a little regulatory myth-busting, and plenty of “did they really just say that?” moments. Because if we have to talk about FDA guidance, we’re at least going to make it worth your time.Instagram: Safe and Effective | The Medical Human Factors PodcastInstagram: HFUX Research | Medical Human Factors Bluesky: @safeeffectivepodcast.comBluesky: @hfuxresearch.comGuest: Melissa Lemke Safe and Effective | The Medical Human Factors PodcastHFUX Research | Medical Human FactorsHuman Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development | FDAHost: Heidi MehrzadComparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for IndustryApplying Human Factors and Usability Engineering to Medical Devices
