Abstract
This is a commentary about the evolution of safety reporting, the new FDA Draft Guidance on Safety Reporting and possible paths forward.
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Seltzer, J., Bhattacharyya, A. Safety Reporting: It Can Enter the 21st Century—If We Let It. Ther Innov Regul Sci 52, 354–361 (2018). https://doi.org/10.1177/2168479017732373
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DOI: https://doi.org/10.1177/2168479017732373