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  • Regulatory NewsRegulatory News

    FDA Formally Authorizes New Diagnostic Meant to Help Fight Against Ebola

    The US Food and Drug Administration (FDA) has formally granted clearance to a testing device intended to be used to diagnose patients with the Ebola virus under special, emergency circumstances. 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 meant to bolster the government's ability to respond to health crises, and especial...
  • Regulatory NewsRegulatory News

    FDA, International Regulators Banding Together to Fight Ebola

    Global regulators are banding together in the hopes of accelerating new therapies to treat a large and growing outbreak of the Ebola virus, a type of highly fatal hemorrhagic fever. In a 4 September 2014 statement, a broad coalition of regulatory agencies under the umbrella of the World Health Organization's (WHO) International Coalition of Medicines Regulatory Authorities (ICMRA) said they would be working together "to find innovative solutions to facilitate evaluation ...
  • Regulatory NewsRegulatory News

    FDA Partially Lifts Clinical Hold on Experimental Ebola Treatment

    The US Food and Drug Administration (FDA) has reportedly partially lifted a clinical hold that it had placed last month on one of the only investigational Ebola treatments that has been tested in humans thus far. Background The drug, an RNA interference product known as TKM-Ebola, is manufactured by Tekmira Pharmaceuticals. In a statement on 7 August 2014, Tekmira said that FDA had "verbally confirmed" that it had modified its clinical hold on the drug. The hold was...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: What You Need to Know About the Regulation of Ebola Treatments

    Unless you've been living under a rock this month, you've undoubtedly heard about a massive outbreak of the Ebola virus in western Africa. The virus is poorly understood, exceedingly rare and, most importantly, incredibly deadly. But what you probably haven't heard about is how treatments for Ebola are regulated—an oversight we at Focus are keen to correct. In this Regulatory Explainer , we're taking a look at the regulations that surround the development of a pote...