FDA Draft Guidance - Comparative Use HF Studies in an ANDA

In January, 2017 the US FDA published a draft guidance, Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry. Since then a number of friends, colleagues, and clients have asked me about my thoughts. It takes a while to read through, but I found the draft guidance helpful in clarifying expectations for companies trying to bring to market generic combination products using the abbreviated new drug application (ANDA) pathway. Some key take-aways: Combination products within the scope of this guidance are those with a drug primary mode of action, so CDER has primary jurisdiction and will coo


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