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  • Regulatory NewsRegulatory News

    HHS Says it Will Shield Maker of Ebola Therapy ZMapp from Legal Liability

    The US Department of Health and Human Services (DHHS) says it will shield the manufacturer of the investigational Ebola virus treatment ZMapp from legal liability under a federal law intended to incentivize the development of new medical products for medical emergencies. Background Under emergency scenarios—the outbreak of a new disease or a disaster—federal legislation permits the US Food and Drug Administration (FDA) to authorize the use of new medications and medical...
  • Regulatory NewsRegulatory News

    In Fight Against Ebola, Device Company Seeks FDA Approval Through Rarely Used Pathway

    In the battle against the Ebola virus, perhaps no weapons have been as sought after as new treatments and diagnostic products to help keep the virus in check and patients safe from harm. But since the start of the outbreak in 2014, one regulatory standard has been an elusive goal for these medical products: Approval. To date, no product has received the full approval of the US Food and Drug Administration (FDA). Now one company is hoping to change that. Seeking Approval ...
  • Regulatory NewsRegulatory News

    An Argument for Emergency Authorization During Public Health Crises

    When a public health crisis like Ebola emerges, public health officials need the flexibility to respond quickly and effectively. But as a new paper in the journal Public Library of Science - Medicine (PLoS Medicine) argues, many countries currently have in place regulatory hurdles which would delay access to experimental new emergency treatments during such crises. Background Many global healthcare product regulators have in place provisions designed to speed ac...
  • Regulatory NewsRegulatory News

    WHO Gives OK to First Rapid-Result Ebola Diagnostic

    The World Health Organization (WHO) has approved the first rapid-result diagnostic test for detecting Ebola. The product, known as ReEBOV Antigen Rapid Test, can help health care workers quickly confirm suspected cases of Ebola. Despite international efforts, Ebola has caused more than 9,400 deaths in West Africa since the outbreak began in March 2014. Rapid Results ReEBOV has a number of advantages over other diagnostics. The product is simple to u...
  • Regulatory NewsRegulatory News

    FDA's CBER Announces Plans to Release Guidances on Gay Blood Ban, Ebola and More

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) plans to release nearly a dozen guidance documents this year, including a massively anticipated document outlining planned changes to its "donor deferral policy" that now prevents most homosexual men from donating blood. FDA's guidance documents are its interpretations of regulations and legislation, which serve to "guide" persons or companies to a state of compliance. While t...
  • Regulatory NewsRegulatory News

    Obama Signs Special Ebola Incentive Program Into Law

    President Barack Obama has signed a new bill into law allowing any pharmaceutical or biotechnology company that successfully develops a product to treat the Ebola virus to obtain a special voucher potentially worth millions—and even billions—of dollars. The law, Adding Ebola to the FDA Priority Review Voucher Program Act , was signed into law by Obama on 16 December 2013. The law focuses on FDA's neglected tropical disease priority review voucher (PRV) program, a pro...
  • Regulatory NewsRegulatory News

    Federal Commission Prepares to Weigh in on Ethics of Testing Ebola Treatments

    President Barack Obama's bioethics commission is preparing to weigh in on whether the US Food and Drug Administration (FDA) should require manufacturers of investigational products intended to either treat or prevent the Ebola virus to run clinical trials with placebo controls. Are Placebos Ethical? The issue of placebo controls has been a contentious one to regulators and ethicists around the globe. At issue: Since Ebola has such a high rate of mortality, should all ...
  • Regulatory NewsRegulatory News

    US Government Immunizes Future Manufacturers of Ebola Vaccines from Legal Liability

    The US Department of Health and Human Services (DHHS) is providing a gift to manufacturers of prospective vaccines meant to protect patients against the Ebola virus: Protection from legal liability. In an announcement in the 9 December 2014 edition of the Federal Register , DHHS said it was issuing a new declaration that would "provide liability protection for activities related to Ebola virus disease vaccines consistent with the terms of the declaration." Protection f...
  • Feature ArticlesFeature Articles

    Applying Ethics to Conflicting Healthcare Philosophies: The Ebola Example and the RAPS Ethics Code

    The Ebola crisis has brought more than anxiety to the US; it has brought controversy in the form of conflicting treatment recommendations for individuals returning from African countries affected by hemorrhagic fever disease. How does a regulatory professional determine how to respond in the face of conflicting philosophies on best practice for developing a treatment or prevention protocol? This article looks at the Regulatory Affairs Professionals Society (RAPS) Co...
  • Regulatory NewsRegulatory News

    Legislation to Increase Regulatory Incentives to Fight Ebola Awaits Obama's Signature

    The US House has quickly passed legislation making changes to the  Neglected Tropical Disease Priority Review Voucher  (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular to those developing new treatments for the Ebola virus. S.2917 , the  Adding Ebola to the FDA Priority Review Voucher Program Act , passed the US House of Representatives by unanimous consent on 3 December 2013, just one day after the same bill was pas...
  • Regulatory NewsRegulatory News

    Ebola Voucher Bill Clears Senate, on Course to Become Law

    The US Senate has passed legislation that would overhaul the Neglected Tropical Disease Priority Review Voucher  (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular those developing new treatments for the Ebola virus. S.2917, the Adding Ebola to the FDA Priority Review Voucher Program Act , passed the US Senate by unanimous consent on 2 December 2013. "Today the Senate took a strong step to support that mission by pass...
  • Regulatory NewsRegulatory News

    US Congress Pushes Ahead With Legislation to Reform FDA Voucher Program

    Both the US House of Representatives and Senate are moving forward with identical pieces of legislation meant to overhaul the Neglected Tropical Disease Priority Review Voucher (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular those developing new treatments for the Ebola virus. Bill Background The legislation, the Adding Ebola to the FDA Priority Review Voucher Program Act , would make three notable changes...