21 U.S. Code § 355g - Utilizing real world evidence
In this section, the term “real world evidence” means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials.
Not later than 2 years after December 13, 2016, the Secretary shall establish a draft framework for implementation of the program under this section.
In developing the program framework under this subsection, the Secretary shall consult with regulated industry, academia, medical professional organizations, representatives of patient advocacy organizations, consumer organizations, disease research foundations, and other interested parties.
The Secretary shall, not later than 2 years after December 13, 2016, and in accordance with the framework established under subsection (c), implement the program to evaluate the potential use of real world evidence.
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