Welcome to another episode of our podcast series, “Q&A with FDA”, from the FDA’s Division of Drug Information, where we answer some of the most frequently asked questions that we’ve received. In a previous episode, we discussed FDA’s Overdose Prevention Framework with Dr.
ORA to shed more responsibilities as the FDA focuses the likely-to-be renamed field organization more on inspections while revamping the agency's Human Food Program.
Expanding ways to generate evidence can lead to an array of benefits for medical product development, including more diverse patient representation and the potential to expedite the availability of safe and effective therapies. As data sources outside of traditional clinical trials become more accessible and methods for analyzing such sources become more robust, there are further opportunities to use real-world data (RWD) to evaluate safety and support evidence of effectiveness.
