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[15] The Eleventh Circuit has overruled an MDO on the basis that FDA failed to fully review applications that did not include randomized control studies without directly addressing the issue of whether the change in guidance itself was arbitrary and capricious

*Correspondence: Kelin Xu, [email protected] Liu, [email protected] These authors have contributed equally to this work and share first authorship This article was submitted to Cardiovascular Epidemiology and Prevention, a section of the journal Frontiers in Cardiovascular Medicine Disclaimer All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers

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Extent of disease In 2013, Rink et al

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