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The (POGO) Blog

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 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

October 20, 2015

By David S. Hilzenrath

FDA Approves Antidote for Pradaxa, Calls It “Necessary”



Blood Sample Scientist Lab Five years after approving the blood thinner Pradaxa without an antidote, the FDA approved an antidote and said it was “medically necessary” when bleeding “can’t be controlled."

Continue Reading FDA Approves Antidote for Pradaxa, Calls It “Necessary”

Topics: Public Health and Science

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