• Regulatory NewsRegulatory News

    HHS Says it Will Shield Maker of Ebola Therapy ZMapp from Legal Liability

    The US Department of Health and Human Services (DHHS) says it will shield the manufacturer of the investigational Ebola virus treatment ZMapp from legal liability under a federal law intended to incentivize the development of new medical products for medical emergencies. Background Under emergency scenarios—the outbreak of a new disease or a disaster—federal legislation permits the US Food and Drug Administration (FDA) to authorize the use of new medications and medical...
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    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...
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    As Ebola Catches Attention of Congress, FDA Emergency Preparedness Bill Becomes Campaign Fodder

    In March 2013, US President Barack Obama quietly signed into law the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) , a biodefense bill which gave the US Food and Drug Administration (FDA) new authority to preemptively prepare for potential pandemics or biological threats. But while the bill received little attention and even less congressional opposition at the time, an outbreak of Ebola in West Africa is now making the bill's passage—and FDA's ...
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    FDA Again Exercises Rarely-Used Emergency Approval Authority

    Citing continued risks to human health, the US Food and Drug Administration (FDA) has once again granted market access for an in vitro diagnostic device meant to detect the H7N9 influenza virus, using its emergency authority under a little-known law. 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 govern...