This on-demand training course will provide learners with an overview of FDA’s approach to the regulation of combination products, including a review of FDA’s recent guidance. Topics will cover processes to streamline and integrate the development of single-entity, co-packaged, and cross-labeled products, approaches to aligning requirements between drugs and devices, and assuring successful human factors interface. Course material will additionally address FDA’s expectation for post-marketing activities, including safety reporting and manufacturing modifications.

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