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  • Regulatory NewsRegulatory News

    FDA Identifies ARBs Without Impurities

    For the first time since the US Food and Drug Administration (FDA) discovered a nitrosamine impurity in angiotensin II receptor blockers (ARBs) last summer, the agency has now identified 40 ARBs and counting that do not contain a nitrosamine impurity. “Our goal is for this information to help health care providers as they consider acceptable treatment options for their patients,” outgoing FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock said in a joint s...
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    EMA Follows FDA Warning on Xeljanz Blood Clot Risks

    The European Medicines Agency (EMA) on Wednesday warned patients and healthcare professionals against exceeding the recommended dose of Pfizer’s rheumatoid arthritis (RA) drug Xeljanz (tofacitinib) due to an increased risk of blood clots forming in the lungs.   EMA’s warning comes less than a month after the US Food and Drug Administration (FDA) issued a similar warning after identifying the risk during an ongoing postmarketing safety study for the drug. In the lat...
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    FDA Warns Cord Blood Marketer, Reiterates Enforcement Discretion

    The US Food and Drug Administration (FDA) on Thursday released a warning letter sent late last month to San Diego-based umbilical cord blood product producer Genetech for selling unapproved products. The warning letter comes as FDA and the Centers for Disease Control and Prevention have received numerous reports of safety issues including those involving microbial contamination and are aware of 12 patients who received Genetech products and subsequently became ill due t...
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    FDA Finalizes Chagas Disease Guidance for Blood Collection Establishments

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on the use of serological tests to reduce the risk of transmission of T. cruzi , a parasite that causes Chagas disease, in blood and blood components. This guidance supersedes 2010 guidance and finalizes a draft from 2016 that amended the 2010 guidance by expanding its scope to include the collection of blood and blood components for use in manufacturing a product, including donations intende...
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    Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test

    As part of an agreement reached with Arizona attorney general Mark Brnovich, the medical device startup Theranos on Tuesday agreed to pay $4.65 million for about 1.5 million blood tests sold to more than 175,000 Arizonans. The deal was forged after Theranos said it ultimately had to void or correct over 830,000 test results, which was about 11% of all results. A day earlier, Theranos announced it would settle with the federal Centers for Medicare & Medicaid Se...
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    FDA Calls Out Unproven Claims of Unapproved Blood Device

    Earlier this month, the US Food and Drug Administration (FDA) released a letter sent to Dr. PRP America for claims made on its website for an unapproved medical device that the San Diego-based company claims can help concentrate and extract blood platelets, as well as adjust blood plasma levels. Mary Malarkey, director of the Office of Compliance and Biologics Quality at FDA’s Center for Biologics Evaluation and Research, wrote in the letter that a review of FDA’s databa...
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    FDA Finalizes Two Guidance Documents on Blood Glucose Monitoring Systems

    • 07 October 2016
    The Food and Drug Administration (FDA) on Friday finalized two guidance documents related to blood glucose monitoring systems (BGMSs), offering new recommendations on the different types of information in 510(k)s for BGMSs used by health professionals versus SMBGs intended for home use by lay users. FDA says the guidance was necessary as it has become increasingly clear that these different use settings have distinct intended use populations with unique characteristics...
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    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...
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    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...
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    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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    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...