For years the FDA has requested device and Rx manufacturers to conduct human factor studies, sometimes also referred to a usability studies. In contrast to label comprehension studies, which assess the extent to which consumers understand the information on drug product labeling (see FDA LCS Guidance here), the intent of human factors research is to evaluate the user interface of a product, or in other words the ability of users to follow and actually perform the needed instructions in a way that eliminates or mitigates potential use-related hazards. In February of this year, the FDA issued draft guidance on how to conduct these studies for combination products (e.g. products comprised of both a drug and a device).
In the last few years the Division of Nonprescription Drug Products (DNDP) has begun to make more requests of OTC sponsors to conduct human factors studies when a proposed OTC product requires consumers to do something more than just take a pill (for example, prime a device prior to administering a dose, or correctly spray the product into the nose or mouth in the case of inhalers).
Most clients know the work PEGUS Research does in support of Rx-to-OTC switch and OTC brand line extension programs (including Drug Facts Label development and the design and conduct of label comprehension, self-selection and actual use studies). However, some may not yet know PEGUS also conducts human factors studies for OTC combination products to address specific research needs and requests from the Agency. We have supported a number of human factors studies for OTC clients. If you have questions about ways PEGUS can assist with human factors research, please contact us at 801-487-9899 or visit our website at http://www.pegus.com/human-factors-research.html.
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