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.

The Food and Drug Administration has provided an update on its proposal to create a unified Human Foods Program, which includes a new model for the Office of Regulatory Affairs.

Scott Melville, president of the Consumer Healthcare Products Association, released the following statement today in response to the update:

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