• Regulatory NewsRegulatory News

    MHRA Joins other UK Agencies on Consolidated Website

    The UK’s Medicines and Healthcare Products Regulatory Agency’s (MHRA) this week announced major changes to its website meant to incorporate it more thoroughly into the UK government's main website. MHRA announced its plans to move from the old website (www.mrha.gov.uk) to www.gov.uk/mhra in April 2014. The new website launched on 28 January 2015 with a design that incorporates feedback from users on how they use the MHRA website and the Drug Safety Update system. Diffe...
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    Will FDA Have to Change its Name? New Bill Takes the 'Food' out of FDA

    If a new bill introduced in Congress this week is ultimately passed, the US Food and Drug Administration (FDA) might soon need to change its 85-year-old name—and give up all of its authority to regulate food, including dietary supplements. The bill, known as the Safe Food Act of 2015 , is set to strip several regulatory bodies of their authority to regulate food products and transfer that authority to a new regulator, the Food Safety Administration (FSA), whose sole j...
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    Tired of Problems With Infusion Pumps, FDA is Trying to Make Them Safer

    US regulators have finalized a new set of recommendations intended to make infusion pumps safer and more reliable. Background In the US, medical devices can come to market in a variety of different ways. Some low-risk devices, known as Class I medical devices, need only to adhere to established standards for a device to be able to be legally marketed. On the opposite spectrum, high-risk, Class III medical devices must undergo a thorough review process in which they need...
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    FDA Considers New Approach Toward Regulation of Dietary Supplements

    When you think of the word "book," chances are good it conjures of images of libraries and well-worn tomes. But at the US Food and Drug Administration (FDA), the word is more often associated with several databases used to keep track of critical information about the products regulated by the agency. Its "Orange Book," for example, keeps track of information regarding which products are bioequivalent to other drugs, while its newly launched Purple Book is set to do the sa...
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    Legislators Call for FDA to Further Restrict Use of Phthalates in Medicines, Citing Risks

    In December 2012, the US Food and Drug Administration's (FDA) drug regulatory body, the Center for Drug Evaluation and Research (CDER), indicated that it wanted to limit the use of some phthalates as excipients in medicines. Now two legislators have a message for the agency: There's more that needs to be done. Background FDA's December 2012 guidance, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products , explained that the agency had foun...
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    ONC Director Defends Health IT Safety Center as it Struggles to Take Shape

    • 21 July 2014
    In response to pressure from members of Congress, a group of federal health IT regulators is clarifying which authorities a proposed Health IT Safety Center would—and would not —have. Background In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed into law, and with it a requirement that US Food and Drug Administration (FDA), the Office of the National Coordinator (ONC) for Health IT and the Federal Communication Commission all work...
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    New Drug Safety Monitoring Fees Come Into Effect in Europe

    User fees paid by pharmaceutical companies, intended to fund regulatory activities by offsetting their expense, are set to rise in Europe under a new regulation published this week. The fees are intended to pay for new pharmacovigilance activities—basically the monitoring of medicines after their initial approval—that were required under legislation passed in 2010 and amended in 2012. The law, known as the pharmacovigilance legislation , is intended to centrali...
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    Researchers Say FDA Should Take More Active Role in Disseminating Drug Safety Warnings

    In addition to approving products and making sure bad ones never make it to market, an indispensable role of healthcare product regulators is warning consumers and healthcare professionals about new risks associated with already-approved healthcare products. The US Food and Drug Administration (FDA) regularly sends out such warnings, generally known as drug safety communications , and as of 27 June 2014 had already issued 12 warnings in 2014—an average of two per ...
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    FDA Recommends Against Use of Painkillers for Teething Pain

    US Food and Drug Administration (FDA) regulators are warning that young children who are teething and experiencing pain should not be given lidocaine, a topical painkiller, due to the serious and even fatal risks associated with the drug. In a 26 June announcement , FDA said that the application of oral viscous lidocaine 2% solution had been associated with at least 22 reports of serious adverse reactions, "including deaths," in young children and infants. At leas...
  • Safety Concerns Related to Global Biosimilars Drug Development

    An initial unfortunate experience in the late 1990s served as an alert to the inherent risks of making apparently small changes to a biological product. The changes by the manufacturer to the formulation of erythropoietin, marketed as Eprex (epoetin alpha), resulted indirectly in the induction of an immune response, which manifested as a dramatic increase in the frequency of cases of pure red cell aplasia, 1 requiring some patients to have blood transfusions and dialysis...
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    EMA Establishes Pharmacovigilance Framework for New Literature Monitoring Efforts

    In regulatory circles, reading literature isn't something that's necessarily done for fun. Instead, regulatory professionals are frequently charged with reading up on the latest literature—scientific literature, that is—mentioning their products in the hopes of discovering reports of dangerous side effects or other potential problems, such as mix-ups or inadequate use or abuse. Background Regulators use reports based on this literature differently. In most regions...
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    Public Citizen Again Calls for Ban on Diabetes Drug Victoza

    A prominent consumer watchdog group is calling on the US Food and Drug Administration (FDA) to withdraw its approval of the diabetes drug Victoza (liraglutide), which it says is linked to acute pancreatitis and several deaths. Background Victoza was approved by FDA in 2010 as a once-daily injectable treatment for Type 2 diabetes. The drug is an incretin mimetic drug known as a glucon-like peptide-1 (GLP-1) receptor agonist. At the time of its approval, FDA noted...