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The (POGO) Blog

February 1, 2016

By David S. Hilzenrath

New Cloud over Clinical Trial Led by FDA Nominee



Robert Califf FDA A court filing in litigation over the blood thinner Xarelto casts a new cloud over a clinical trial co-chaired by Robert Califf, who President Obama has nominated to be FDA commissioner.

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Topics: Public Health and Science

December 23, 2015

By David S. Hilzenrath

After Problems Revealed, FDA Seeks Solutions for Blood Testing Devices



Picture of a drop of blood on thumb. The FDA has scheduled a public meeting to discuss issues related to the safety and effectiveness of point of care PT/INR blood testing devices. The devices measure the clotting rates of patients on the blood thinner warfarin and are used to prevent incorre

Continue Reading After Problems Revealed, FDA Seeks Solutions for Blood Testing Devices

Topics: Public Health and Science

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

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