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  • Regulatory NewsRegulatory News

    Congressman, Consultant Discuss Goals in Raising Claims About Essure

    Editor's note: Last week Focus reported on allegations made by Rep. Mike Fitzpatrick (R-PA) about the permanent birth control device Essure. During the call, Fitzpatrick claimed that Essure was associated with 303 reports of fetal deaths and raised allegations that Conceptus, Essure's original manufacturer, provided illegal kickbacks to doctors to promote use of the device. Please see our previous coverage of the allegations and follow up discussion of those alleg...
  • Regulatory NewsRegulatory News

    New Updates to FDA's Website Make it Easier to Track Device Recalls, Drug Changes

    US regulators have announced the release of a treasure trove of data regarding medical device recalls and drug labeling, the latest releases under the US Food and Drug Administration's (FDA) new openFDA program. Background The openFDA initiative was born from a May 2013 order from the White House instructing federal agencies to begin implementing a new "digital strategy" aimed at making governmental information more readily available and accessible to the public. At th...