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  • Regulatory NewsRegulatory News

    Updated: The Next Theranos? FDA Warns Qiagen Over Faulty TB Test Device

    The US Food and Drug Administration (FDA) on Tuesday released a warning lettter for Maryland-based Qiagen over deficiencies with its blood test used for diagnosing tuberculosis (TB), noting multiple complaints for high false positive rates. FDA’s inspection found that Qiagen’s QuantiFERON-TB Gold (QFT) test device, first approved in 2005, “is adulterated … in that the methods used in or the facilities or controls used for, their manufacture, packing, storage, or installa...
  • Regulatory NewsRegulatory News

    Health Canada Finalizes IVD Labeling Guidance After 18 Years

    The Canadian regulatory agency Health Canada on Friday finalized its guidance for labeling in vitro diagnostic (IVD) devices nearly 18 years after releasing the draft version in 1998. The final guidance includes new considerations for electronic labeling, IVDs with small containers, blood glucose monitors and information on complying with Canada's Official Languages Act , which requires product labels to be written in both French and English. Additionally, the guidance...
  • Regulatory NewsRegulatory News

    Zika: FDA Recommends Deferring At-Risk Blood Donors for Four Weeks

    The US Food and Drug Administration (FDA) is recommending blood banks defer donations from recent travelers to Zika-affected countries. The recommendation comes in the form of a new guidance released today, intended to reduce the risk of Zika virus (ZIK V) entering the nation's blood supply by establishing screening procedures to prevent infected donors, especially those who are asymptomatic, from giving blood. The guidance, which enters into effect immediately, recomme...
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    House Committee Seeks More Info from FDA on Safety of Blood Thinners

    The House Committee on Energy and Commerce sent a letter Wednesday to acting US Food and Drug Administration (FDA) Commissioner Dr. Stephen Ostroff requesting more information on the safety of popular blood thinners Coumadin and its generic warfarin. The letter cites a ProPublica report from earlier this summer that noted a high prevalence of adverse events tied to the use of these anticoagulants, particularly among nursing home residents. That report also notes that l...
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    EMA Releases Draft Guideline on Epidemiological Data Requirements for Plasma-Derived Products

    The European Medicines Agency (EMA) has released a draft Guideline on epidemiological data on blood transmissible infections intended to provide clarification on the data requirements for plasma-derived products. Background In the EU, companies must submit scientific data for blood- or plasma-derived medicinal products using the plasma master file (PMF) certification procedure. The requirement for PMF certification was established in Directive 2003/63/EC , which ...
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    New Report Looks at Challenges to Availability of Blood, Plasma in EU

    A new report from Creative Ceutical examines the availability of blood products in the EU and addresses some of the regulatory challenges impacting their supply. The report, An EU-wide overview of the market of blood, blood components and plasma derivatives focusing on their availability for patients , was commissioned by the European Commission’s Executive Agency for Health and Consumers (EAHC), and features commentary by stakeholders from various industry groups, pati...
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    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...
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    FDA Clarifies Syphilis Screening Procedures for Blood, Plasma Donations

    • 28 August 2014
    A new guidance document issued by the US Food and Drug Administration (FDA) finalizes an earlier draft set of recommendations on how blood and plasma collection centers can screen donors and samples for syphilis. Background Blood and plasma donations, like the donation of all cell and tissue products, are already subject to a battery of tests to ensure they are not contaminated with any serious diseases. At present, those tests include ones to detect hepatitis B and C, ...
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    India’s CDCSO Establishes New Testing Requirements for Blood Glucose Strips

    India’s Central Drugs Standard Control Organization (CDSCO) is looking to tighten the regulation of blood glucose testing supplies, it announced last week. In a 7 August 2014 notice issued to all local State Drugs Controllers and port authorities, CDSCO ordered that importers and manufacturers of blood glucose test strips and analyzer based glucose reagents must provide three batches for testing at the National Institute of Biologicals in Noida.  Following the testin...
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    FDA to Focus on Blood, Platelet Disorders at Upcoming Meeting With Patients

    US regulators have announced they will soon hold their tenth patient-focused drug development meeting, this time focusing on a collection of blood and platelet disorders that includes hemophilia A, hemophilia B, and von Willebrand disease. Background The meetings are required under the Food and Drug Administration Safety and Innovation Act (FDASIA) , Section X of which called for the US Food and Drug Administration (FDA) to meet with patients in order to better un...
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    New Blood Clot Warnings Added to Labels of Testosterone Products

    The US Food and Drug Administration (FDA) yesterday said it will require manufacturers of testosterone products about an increased risk of venous blood clots, known as venous thromboembolism (VTE)—the latest warning for a class of drugs that has seen no shortage of scrutiny from regulators and researchers alike. Background Testosterone products, commonly used to treat low levels of testosterone in men, or "low-t," have long been associated with higher risks of so...
  • Hundreds of Comments Already in Hand, FDA Extends Comment Period for Duo of Diabetes Guidances

    The US Food and Drug Administration (FDA) has announced that it will extend the comment period for two recently released draft guidance documents intended to help the medical device industry to develop blood glucose monitoring devices intended for both home and point-of-care use. Background FDA's duo of draft guidances, released in January 2014, called for a new regulatory approach toward blood glucose test systems based on their location of use. Regulators cited the d...