Safety and Usability Related to Design Modification for a Drug Delivery Device

A pharmaceutical manufacturer wanted to change the design of the device constituent part of a prefilled delivery device. An s-NDA was filed for the design change. FDA issued a Complete Response Letter expressing safety and usability concerns. A Type C Meeting was established to discuss FDA’s concerns and provide responses to these concerns. Chimera assisted the pharmaceutical manufacturer in its preparation for the meeting by reviewing the Complete Response Letter and by providing comments on the meeting briefing document, which included a risk assessment and mitigation information and a human factors study protocol.