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OPQ urges applicants to 'know your product and the RLD' and to engage early with reviewers
Summary
The presenter advised applicants to understand the reference listed drug (RLD), plan control strategies for device characteristics, include preconditioning and stability data, and request early joint meetings with CDER and CDRH to avoid approval delays.
The presenter closed with actionable recommendations for applicants preparing generic combination-product submissions. She recommended understanding the RLD device when designing a test product and said sponsors should "understand critical quality considerations and device performance recommendations for drug device combination products, communicate early with the agency." She emphasized proposing a control strategy for device characteristics that relate to drug delivery and including preconditioning and worst-case stability data with justification.
She also encouraged early interaction with the agency, including joint meetings with CDER and CDRH, to outline proposed steps to ensure connectivity (device compatibility) and avoid review delays. The presenter concluded by acknowledging colleagues and handing the presentation to the next panelist.
