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The (POGO) Blog

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.

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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

October 15, 2015

By David S. Hilzenrath

Drug Problems: Dangerous Decision-Making at the FDA



Emergency Room Gurney 120 When it comes to prescription drugs, how much comfort should consumers take from the words “FDA approved”? A Project On Government Oversight investigation calls into question the reliability of a crucial regulatory system.

Continue Reading Drug Problems: Dangerous Decision-Making at the FDA

Topics: Public Health and Science

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