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US Drug Delivery Combination Product Regulatory

Published Date: July 14, 2022

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.

Learn more about the presenter below.

Lee Leichter, RAC, MBA

President – P/L Biomedical

Lee Leichter has close to 50 years’ experience in the health care industry, providing direct, hands-on assistance to domestic and international Pharmaceutical, Biotechnology, and Medical Device companies for the last 30. His projects have encompassed a multitude of business, technical, regulatory, and quality issues primarily related to drug delivery and combination products for marketing in the USA, Europe, and Canada. He has worked with large multi-national companies, as well as start-ups, successfully navigating the challenges posed during the development, testing, and marketing approval of products that merge pharmaceutical substances with high-tech device systems.

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