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  • Regulatory NewsRegulatory News

    CDRH to Review Materials Used in Medical Devices

    Following recent high-profile safety issues related to materials used in implantable and insertable medical devices, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren on Friday announced plans to improve the agency’s approach to evaluating material safety and biocompatibility.   “Modernizing the regulatory framework pertaining to the FDA’s review of medical device materials requi...
  • Regulatory NewsRegulatory News

    Reps Question Gottlieb on Bayer's Follow-Up Essure Studies

    Reps. Rosa DeLauro (D-CT), Jan Schakowsky (D-IL) and Louise Slaughter (D-NY) on Monday sent a letter to FDA Commissioner Scott Gottlieb regarding concerns related to Bayer's postmarket study for its permanent birth control device Essure. A year and a half after Bayer's postmarket study was initiated, "It is unclear whether Bayer acted with urgency to enroll patients, or if the study results will be delayed. The FDA cannot continue to allow Bayer to drag its feet on...
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    FDA Approves New Labeling for Essure, Closes Trade Complaint Against Bayer

    The US Food and Drug Administration (FDA) on Tuesday said it has approved new labeling for Bayer's permanent birth control device Essure, in line with the agency's recently finalized labeling guidance . With the approval of the new labeling, FDA said it has also closed its investigation of a trade complaint , initially filed as a citizen petition , against Bayer concerning the device. FDA spokesperson Angela Stark told Focus the investigation included a review of E...
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    FDA Finalizes Guidance on Boxed Warning, Patient Decision Checklist for Essure Devices

    The US Food and Drug Administration (FDA) on Friday finalized its guidance requiring a boxed warning and patient decision checklist for Bayer's permanent implantable birth control device Essure. While the final guidance retains most of the recommendations made in the draft version, both the language of the boxed warning and patient decision checklist have been updated. However, these changes are unlikely to settle concerns from patients who say they have been harmed by ...
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    FDA Signs Off on Bayer Study of Essure Following Numerous Adverse Events, Deaths

    The US Food and Drug Administration (FDA) on Friday approved Bayer’s updated postmarket surveillance study plan for its permanent birth control device Essure, which has been linked to four adult deaths, 15 incidences of pregnancy loss and 631 reports of pregnancies in patients with Essure. Although FDA has not pulled the device from the market, in February the agency required Bayer to add a boxed warning to the device and to conduct a surveillance study. From 4 Nov...
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    Health Canada to Develop Better Risk Communications on Essure Contraceptive Devices

    Canadian drug and device regulator Health Canada on Monday said it is working with Bayer to develop better risk communication for the permanent birth control device Essure after a safety review of the device found the its risks are not adequately communicated. The agency also says it is working with Bayer to update Essure's labeling and says it will increase its monitoring of the device. Background and FDA Review Essure is marketed as a non-surgical alternative to tuba...
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    FDA: New Postmarketing Study, Black Box Warning for Essure

    This article has been updated with more information presented by FDA in a press call Monday and the release of the draft guidance referenced in FDA's announcement. After months of deliberation, the US Food and Drug Administration (FDA) announced on Monday that it will require a new postmarketing study and a black box warning label for Bayer's permanent birth control device Essure. Essure is marketed as a non-surgical alternative to tubal ligation and consists of a pai...
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    Congressional Hearings Focus on Compassionate Use, FDA Issues

    Aside from Thursday’s summit on President Barack Obama’s Precision Medicine Initiative (which can be viewed in its entirety  here ), the Senate and House held two other hearings focused on the inner workings of the US Food and Drug Administration (FDA). At the Senate Homeland Security and Government Affairs Committee hearing, senators discussed FDA’s compassionate use program with the Goldwater Institute’s Dary Olsen, who’s been behind all of the Right-to-Try state legi...
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    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

    Bayer Refutes Congressman's Claims on Essure Safety

    Editor's Note: On Wednesday, Focus reported allegations raised by Rep. Mike Fitzpatrick (R-PA) during a press call that Bayer's permanent birth control device Essure is associated with far more reports of fetal death than previously reported by the US Food and Drug Administration (FDA). After publication we received a statement from Bayer Healthcare refuting those allegations. In this article we discuss Bayer's response and clarify certain aspects of the claims made...
  • 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...