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  • Regulatory NewsRegulatory News

    Canada Launches Ebola Vaccine Trial

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The Canadian Institutes of Health Research (CIHR) and the Public Health Agency of Canada (PHAC) have provided funding for a Phase I clinical trial using Canada’s Ebola vaccine (VSV-EBOV), Canada's Minister of Health, Rona Ambrose, announced last week.  The Canadian Im...
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    FDA Authorizes Sixth Device to Help in Fight Against Ebola

    The US Food and Drug Administration (FDA) has once again given its blessing to a new diagnostic tool meant to help identify treatments for Ebola—the sixth time it has used its emergency authority to do so in the last four months. Background In March 2013, FDA was given a host of new authorities and responsibilities under the  Pandemic and All-Hazards Preparedness Reauthorization Act ( PAHPRA ) , a piece of legislation intended to bolster the government's ability to ...
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    US Senate Unveils Major Changes to FDA Program in Hopes of Fighting Ebola

    Legislators in the US Senate have unveiled a new piece of legislation meant to incentivize companies to go after the Ebola virus by making critical and long-sought changes to a US Food and Drug Administration (FDA) regulatory program. Background As Focus explained in October 2014 , a recent outbreak of Ebola has led to a scramble for new drugs and vaccines to help treat and prevent the virus. At present, there are no recognized treatments for the disease. Some publi...
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    Swiss Regulators Approve Ebola Vaccine Trial Meant to Protect Medical Volunteers

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Swiss healthcare product regulator Swissmedic has approved an application to start a clinical trial for an experimental Ebola vaccine at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, the regulator announced on 27 October 2014. Given the severity of ...
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    Senators Call for Expansion of FDA Program to Help Fight Ebola

    Bipartisan members of the US Senate's healthcare oversight committee plan to introduce legislation that would amend a little-used regulatory program in the hopes of spurring the development of treatments for the Ebola virus. Background The program, known as the neglected tropical disease priority review voucher program, was created in 2007 under the Food and Drug Administration Amendments Act (FDAAA) . The voucher program, first envisioned in a 2006 Health Affairs po...
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    Company, Warned by FDA Over Improper Marketing, Petitions Regulators for Redress

    Most Warning Letters sent by the US Food and Drug Administration (FDA) are met by their recipients with a sense of loathing and urgency. A failure to respond to a letter quickly and appropriately can lead to major sanctions against a company, to say nothing of the damage a bungled response can do to a company's reputation. But one company, cited by FDA in September 2014 Warning Letter alleging that it improperly marketed a product to treat Ebola, is fighting back in an u...
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    FDA Authorizes Use of New, Substantially Faster Ebola Diagnostic Tests

    The US Food and Drug Administration (FDA) has granted emergency use authorizations (EUAs) to two new diagnostic tests meant to help health professionals to accurately diagnose the Ebola Zaire virus in record time. Background In March 2013, FDA was given a host of new authorities and responsibilities under the  Pandemic and All-Hazards Preparedness Reauthorization Act  ( PAHPRA ), a piece of legislation intended to bolster the government's ability to respond to health ...
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    Europe Establishes Roadmap for Companies Hoping to Get Ebola Treatments Approved

    The European Medicines Agency (EMA)—Europe's equivalent to the US Food and Drug Administration (FDA)—says it stands ready, willing and able to help accelerate the evaluation of new medicines and vaccines meant to treat a global outbreak of the Ebola virus. Earlier this week, the agency said it was encouraging companies to apply for orphan designation for their products—a designation intended to accelerate the review of products by allowing companies to access thorough sc...
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    To Meet Ebola Threat, Father of FDA's Priority Review Voucher System Calls for Reforms

    One of the fathers of a little-known and lesser-used regulatory pathway meant to incentivize the approval of new drugs for so-called "neglected tropical diseases" says Congress needs to include Ebola on the short list of diseases eligible for incentives. Background So called "tropical" diseases are  defined by statute  as infectious diseases which do not affect developed nations and disproportionately affect poor and marginalized nations. Such diseases are typically not...
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    With $5 Million Grant, FDA Wants to Change how the US Responds to Future Public Health Emergencies

    A new $4.9 million contract awarded by the US Food and Drug Administration (FDA) seeks to improve how the agency deploys medical countermeasures during public health crises like Ebola. Background "In emergency situations, rapid response is critical," FDA writes on its website. And while that response often includes basic provisions—money to buy supplies and the deployment of healthcare providers to an area, for example—it almost always includes medical products like dru...
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    Think Tank Seeks Ebola Info from FDA, Calling it a Test Case for Compassionate Use System

    A libertarian-leaning think tank is pressuring the US Food and Drug Administration (FDA) to release information regarding the internal approval processes it used to permit two US citizens stricken with Ebola access to Mapp Biopharmaceuticals' ZMapp, an experimental drug. Background In August 2014, the American public became fixated on an outbreak of Ebola in West Africa after two US missionaries, Dr. Kent Brantley and Nancy Writebol, became infected with the disease. In...
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    FDA Leverages Compassionate Use Program to Allow Access to Experimental Ebola Drug

    Canadian biopharmaceutical company Tekmira has announced that the US Food and Drug Administration (FDA) will allow its investigational Ebola drug, TKM-Ebola, to be used by patients under an emergency expanded access program—a stark reversal for the product, which two months ago was subject to a complete clinical hold. Background As Regulatory Focus extensively explained in August , developing new treatments for Ebola is a long and arduous process. Because Ebola, a he...