概览
Through a series of recorded sessions and interactive online exercises, this On-Demand Training 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.
This on-demand training course takes an average of 8 hours to complete. Learners have access to the course for one year from the date of purchase.