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  • Regulatory NewsRegulatory News

    What the Incoming Trump Administration may Mean for FDA, Biopharma and Device Companies

    As pharmaceutical and biotech company stocks saw a quick rise in share prices yesterday, investors seem to believe the incoming Donald Trump administration and the avoidance of a California ballot measure on drug pricing will have a positive impact on the sector as a whole, at least financially. But while Trump has called for a reduction of federal regulations in general, it remains to be seen how he will deal with the US Food and Drug Administration (FDA). Steven Gros...
  • Regulatory NewsRegulatory News

    New Bill Would Speed FDA Review of OTC Contraceptives

    Editor's note: This article has been updated to clarify that the Oregon bill allows pharmacists to prescribe certain contraceptive drugs to patients. A new House bill, sponsored by Rep. Mia Love (R-UT), would speed the review of contraceptive drugs by the US Food and Drug Administration (FDA), and includes measures to make the drugs available over-the-counter for adult women. The bill, known as the Over-The-Counter Contraceptives Act , would compel FDA to grant suppl...
  • Regulatory NewsRegulatory News

    Cybersecurity Researcher: Recent Device Vulnerabilities Should Be a Wake-Up Call for FDA

    A prominent cybersecurity researcher says the US Food and Drug Administration (FDA) needs to "buckle down" and regulate medical device cybersecurity more firmly. The warning comes after the US Department of Homeland Security (DHS) issued an advisory last week warning of more than 1,400 cybersecurity vulnerabilities found in third-party software used in CareFusion's Pyxis SupplyStation, an automated, networked, supply cabinet used to store and dispense supplies ranging fr...
  • 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

    Congressman Says More than 300 Fetal Deaths Related to Essure Ahead of FDA Announcement

    Editor's note: After publishing this article, Focus received comments from Bayer refuting the allegations made by Rep. Fitzpatrick. See our coverage of Bayer's comments in a follow up article published Thursday. Rep. Mike Fitzpatrick (R-PA) on Wednesday presented new information raising questions about the safety of the permanent birth control device Essure, claiming the number of fetal deaths related to the device are far greater than what has been reported by the U...
  • Regulatory NewsRegulatory News

    FDA to Announce Next Steps in Essure Review

    The US Food and Drug Administration (FDA) says it plans to make an announcement on the birth control device Essure in February 2016, after the agency completes a "high priority" review of the device's safety. In an update posted to FDA's website Tuesday, the agency says it is reviewing information, including testimony made at a recent advisory panel meeting, medical literature and recent adverse event reports to "identify appropriate next steps." The agency is also cons...