Regulatory Affairs for Combination Products

Learn about FDA's approach to regulation of combination products, the processes to streamline development of single entity, and aligning requirements between drugs and devices.

概览

This introductory course will provide learners with an overview of FDA’s approach to regulation of combination products including review of FDA’s recent guidance. Topics will cover processes to streamline and integrate development of single entity, co-packaged and cross-labeled products. Discussion will cover approaches to aligning requirements between drugs and devices and assuring successful human factors interface. Course material will address FDA’s expectation for post-marketing activities, including safety reporting and manufacturing modifications. Workshops will offer practical applications in when and how to report as a constituent product or as a combination.

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学习目标

At the conclusion of this course, participants should be able to:

Explain the similarities and differences in drug and device regulations
Identify opportunities to streamline single entity compliance by integrating drug and device systems
Discuss risk assessment and management in the combination product environment
Describe the unique requirements of successful combination product development
Explain FDA expectations of combination product applicants and how to work successfully with the agency
Discuss how human factor considerations are assessed and controlled in the drug/device user interface

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Regulatory Affairs for Combination Products

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