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  • Regulatory NewsRegulatory News

    EMA’s CHMP Recommends First Ebola Vaccine, 6 Other Medicines

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced recommendations for seven new medicines for approval, including a conditional marketing authorization for Merck’s Ebola vaccine Ervebo (rVSVΔG-ZEBOV-GP, live), which is the first vaccine for those 18 years and older at risk of infection with the Ebola virus. EMA said that preliminary data suggest the vaccine is effective in the current Ebola outbreak in the De...
  • Regulatory NewsRegulatory News

    FDA Clears First Rapid Diagnostic Test for Ebola

    The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) on Thursday allowed the marketing of the first rapid diagnostic test for the Ebola virus that has not been authorized via the agency’s Emergency Use Authorization (EUA) pathway. OraSure Technologies’ OraQuick Ebola Rapid Antigen Test, which provides a rapid, presumptive diagnosis that must be confirmed, gained market entry via CDRH's De Novo review pathway less than five mont...
  • Regulatory NewsRegulatory News

    FDA Offers 2016 Report on Medical Countermeasure Activities

    As part of efforts to protect the US against chemical, biological, radiological, and nuclear (CBRN) threats, the US Food and Drug Administration (FDA) approved seven new treatments and 21 new devices in FY 2016, according to a program update on medical countermeasure (MCM) activities. With a budget of a little more than $110 million, FDA’s MCM efforts play a  critical role  in protecting the US from dangerous threats and emerging infectious disease threats, such as pand...
  • Regulatory NewsRegulatory News

    Approval of Anthrax Vaccine Under FDA’s Animal Rule is a Step Forward, Researchers Argue

    Although the US Food and Drug Administration’s (FDA) 2015 approval of the vaccine BioThrax for postexposure prophylaxis (PEP) for inhalational anthrax wasn’t the first approval under the rarely used Animal Rule, researchers in Nature explained on Thursday why it is a “significant step forward” in the approval of new vaccines and other medical countermeasures under the pathway. Background The Animal Rule pathway (codified here ) was designed to allow companies to bri...
  • Regulatory NewsRegulatory News

    EMA Adds Four New Drugs to PRIME Scheme

    The European Medicines Agency (EMA) has granted four new drugs eligibility to its PRIority MEdicines (PRIME) scheme, bringing the total number of drugs accepted to the program to eight. Like the US Food and Drug Administration's (FDA) breakthrough therapy program, PRIME aims to streamline the development of promising new therapies through earlier scientific advice and increased engagement between EMA and sponsors in order to facilitate an accelerated product assessme...
  • Regulatory NewsRegulatory News

    Congress Considers Priority Review Vouchers for Medical Countermeasures

    Members of the House Energy and Commerce Oversight and Investigations subcommittee were briefed on recommendations at a hearing Friday for improving the nation's biodefence strategy against natural and man-made threats. The recommendations are particularly timely as legislators and public health officials scramble to mount a response to the Zika virus outbreak across Latin America and the Caribbean. Many of these recommendations come from the Blue Ribbon Study Panel on ...
  • Regulatory NewsRegulatory News

    FDA and EMA Share Perspectives on Evaluating Ebola Treatments

    Officials from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have shared their perspectives on evaluating treatments for Ebola in two articles appearing in Clinical Trials . The articles discuss some of the challenges the Ebola outbreak presented for studying drugs and vaccines to treat the disease. At the time the outbreak began, no products existed to treat Ebola, and those that were in development had not been tested in humans. Study ...
  • Regulatory NewsRegulatory News

    FDA Offers Guidance for Blood Establishments During Ebola Outbreaks

    The US Food and Drug Administration (FDA) has released new recommendations for blood establishments to implement additional screening measures during Ebola virus outbreaks. Background Since the outbreak began in 2014, the World Health Organization (WHO) estimates that there have been more than 28,000 cases of Ebola, resulting in 11,314 deaths. The outbreak has proven particularly difficult for health authorities to quell in Guinea, Sierra Leone and Liberia. In Novembe...
  • Feature ArticlesFeature Articles

    Ebola—Expedited Pathways for Drugs and Vaccines in Europe: The EMA Perspective

    This article discusses the European Medicines Agency (EMA) facilitated expedited pathways for drug and vaccine approval to enable fast access to market to fight emerging diseases, such as Ebola. To date, neither the US Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) has approved a vaccine or therapy for the treatment of the Ebola virus, which in Guinea, Liberia and Sierra Leone has had a case fatality rate as high as 71%. 1 Regulatory a...
  • Regulatory NewsRegulatory News

    Group Sues FDA, Seeking Access to Ebola Information

    A battle over regulatory documents has led a libertarian-leaning think tank, The Goldwater Institute, to sue the US Food and Drug Administration (FDA) in the hopes of compelling the agency to hand over information related to how several US citizens received drugs to treat the Ebola virus. 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 wi...
  • Regulatory NewsRegulatory News

    UK Prime Minister Calls for Greater Clinical Trial Transparency in Emergencies

    In response to the shortfalls in the international response to the Ebola outbreak, UK Prime Minister David Cameron is proposing a plan to boost research and transparency in the hopes of better confronting future public health crises. The Plan Cameron, who spent the past two days with other world leaders from Canada, France, Germany, Italy, Japan, the US and EU at the G7 Summit in Germany, said the world must "be far better prepared with better research, more drug develo...
  • Regulatory NewsRegulatory News

    Public Health Groups Propose Global Drug Innovation Fund

    Two health advocacy groups, Médecins Sans Frontières (MSF) and the Drugs for Neglected Diseases initiative (DNDi) are urging public health authorities to create a global fund to tackle what they call "deadly gaps in innovation." Citing the rising threat of antimicrobial resistance (AMR), emerging infectious diseases and neglected tropical diseases (NTDs), the two organizations say the pharmaceutical industry is failing to address certain public health challenges. Back...