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The (POGO) Blog

December 9, 2015

By David S. Hilzenrath

Leaders of Xarelto Clinical Trial Reaffirm Conclusions



Blood Sample Scientist Lab After reviewing a clinical trial of the blood thinner Xarelto to see if defective testing devices affected the results, leaders of the trial reaffirm their original conclusions.

Continue Reading Leaders of Xarelto Clinical Trial Reaffirm Conclusions

Topics: Public Health and Science

November 30, 2015

By David S. Hilzenrath

Drug Problems: European Regulator Investigating Trial Led by FDA Nominee



1950 Photograph of a Physican and patient. European regulator EMA is investigating a clinical trial of the blood thinner Xarelto, which Robert Califf, President Obama’s nominee for FDA commissioner, helped lead.

Continue Reading Drug Problems: European Regulator Investigating Trial Led by FDA Nominee

Topics: Public Health and Science

November 23, 2015

By Iulia Gheorghiu

Duke Reassessing Data From Clinical Trial Led By FDA Nominee Califf



Photograph of Duke Clinical Research Institute The clinical trial that was the basis for FDA approval of the blood thinner Xarelto for cardiac patients used a line of testing devices that was the subject of two FDA warning letters before the trial began and an FDA recall notice after the trial ended, a

Continue Reading Duke Reassessing Data From Clinical Trial Led By FDA Nominee Califf

Topics: Public Health and Science

November 20, 2015

By David S. Hilzenrath

Drug Problems: Duke Reassessing Data From Trial Led By FDA Nominee



Robert Califf FDA The Duke Clinical Research Institute is reassessing data from a clinical trial of Xarelto that FDA nominee Robert Califf helped lead.

Continue Reading Drug Problems: Duke Reassessing Data From Trial Led By FDA Nominee

Topics: Public Health and Science

November 12, 2015

By David S. Hilzenrath

Drug Problems: Nominee to Head FDA Led Clinical Trial FDA Faulted



Robert Califf FDA Robert Califf, President Obama’s nominee to head the Food and Drug Administration, helped lead a clinical trial that was sharply criticized by FDA reviewers and outside advisors.

Continue Reading Drug Problems: Nominee to Head FDA Led Clinical Trial FDA Faulted

Topics: Public Health and Science

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