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Autor:
Keri L. Monda, Jeffrey S. Riesmeyer, Ricardo Dent, Robert A. Scott, Manisha Desai, Robert LoCasale, Jesse A. Berlin, Joanne Waldstreicher, Jyothis T. George, Cherie Binns, Thomas Hucko, Debbe McCall, Jack Mardekian, Lothar Roessig, Govinda Weerakkody, Harald Siedentop, Stefan Hantel, Shun Fu Lee, Andrea J. Cook, Lin Wang, Tomas Andersson, Adrian F. Hernandez, Carolyn Arias, Denise Esserman, Frank W. Rockhold, Susan S. Ellenberg, Sharon-Lise T. Normand, Mark J. Cziraky, Matthew T. Roe, Lesley H. Curtis, Andrew Emmett, Trevor A. Lentz, Naeem D. Khan, David Martin, Patrick J. Heagerty, Myles Wolf
Publikováno v:
Therapeutic innovationregulatory science. 54(6)
In late 2018, the Food and Drug Administration (FDA) outlined a framework for evaluating the possible use of real-world evidence (RWE) to support regulatory decision-making. This framework was created to facilitate studies that would generate high-qu