This presentation will include a short summary of the types of Drug Delivery Combination products codified by US FDA regulation, and the types of other drug delivery products where the combination must be addressed.
It will detail the current technical expectations for development, incorporating Design Verification approaches, including FDA Essential Performance Requirements (EPRs), recently updated ISO 11608 series, and FDA and IEC requirements for addressing Human factors; and GMP/System requirements required under FDA 21 CFR Part 4 regulations.
Among other areas, the presentation will touch on requirements for clinical requirements and unique challenges for generic products.
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