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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.

Stability studies for prefilled autoinjector

A Pharmaceutical manufacturer developing an injection pen containing a two-chamber drug-diluent cartridge sought Chimera’s advice on establishing methods and specifications for syringibility force testing to be conducted during stability testing. Chimera assisted the manufacturer in establishing specifications and testing methods.