CDER Combination Product Policy Advisor Kristina Lauritsen and CDRH’s James Bertram provide an overview of FDA’s regulation of combination products, discuss changes due to legislative updates, and present CDER and CDRH perspectives. They help identify what is and isn’t a combination product, describe the agency’s assignment of combination products, compare/contrast the regulatory paradigms for CDER and CDRH, review considerations for combination products, and share best practices for combination products and navigating the FDA.

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
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CDER small business e-mail update subscription: [ Ссылка ]

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