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Emergency Response

October 24, 2014 | Daily News

FDA's top official and a key biotechnology trade group official warned that the agency's flexible policies surrounding the Ebola response, including allowing the early use of investigative therapies, might not be applicable in all cases of rare diseases.

October 23, 2014 | Daily News

House Republicans' latest request for details on the Obama administration's efforts to stop the Ebola outbreak from spreading to the United States highlights the need for rapid point-of-care diagnostics.

October 21, 2014 | Daily News

The Centers for Disease Control and Prevention (CDC) has issued sweeping new guidelines for health care workers to prevent the spread of Ebola that recommend standard use of N95 or air-purifying respirators near Ebola, as opposed to earlier guidance suggesting such high-end respirators are only needed during aerosol-generating procedures. The guidance hones in on three key issues regarding use of personal protective equipment (PPE): training; ensuring no skin is exposed; and supervision of employees.

October 20, 2014 | Daily News

Industrial health experts are urgently calling on OSHA, and also taking their case directly to the White House, to move forward as rapidly as possible on a rulemaking to tackle infectious diseases in health care settings -- pressure that follows close on the heels of at least two U.S. health workers testing positive for the Ebola virus.

October 17, 2014 | Daily News

The National Nurses Union said the president's decision to tap a White House Ebola czar falls short unless the administration gives the czar power to cut off Medicare and Medicaid funds at hospitals that don't meet the highest uniform, national workplace safety standards. The union's press comes as worker health and safety advocates urge the Occupational Safety and Health Administration to step up efforts to issue a delayed infectious diseases rule that would protect health care and other workers.

October 16, 2014 | Daily News

FDA and other HHS agencies detailed the multiple steps they are taking to advance treatments for Ebola at a House hearing Thursday (Oct. 16) where the Obama administration faced sharp criticism of its response to the ongoing outbreak. The Biomedical Advanced Research and Development Authority also announced Thursday that it is contracting with Profectus Biosciences Inc.

October 14, 2014 | Daily News

Worldwide concern over outbreaks of Ebola disease has hit home in the U.S. health care sector as a nurse in Dallas who cared for a now-deceased patient with the virus has contracted the disease, despite use of full personal protective equipment (PPE), putting new pressure on employers to institute comprehensive infection control programs that include site-specific training of employees. The nurse's diagnosis represents the first known transmission of the disease within the United States and the first known U.S. health care worker to contract Ebola while treating a patient domestically.

October 07, 2014 | Daily News

Nurses and their supporters across the United States are voicing a variety of concerns about the U.S. health care sector's readiness to provide them with adequate health protections as cases of Ebola infection begin sprouting up outside the disease-ravaged region of West Africa, including a patient in Dallas and most recently a nurse in Spain -- with ensuring adequate protective gear a key priority of advocates.

October 07, 2014 | Daily News

The Occupational Safety and Health Administration reportedly is on the cusp of sending out, as soon as late this month or sometime in November, the necessary materials to start a small business review process on the agency's proposed rulemaking to help prevent workplace exposures to infectious diseases, a source closely following the issue tells Inside OSHA Online.

September 29, 2014 | Daily News

FDA is offering industry sponsors wide flexibility in its quest for speedy development of an Ebola vaccine and treatments: The agency is working with developers to review data for candidate treatments in "real time," encouraging simple trials designs that would allow studies to begin soon in Africa, allowing companies to conduct parts of the study process "in parallel," and holding out orphan drug designation as an incentive. A top agency official said  last week that approval of an Ebola vaccine would be a "game changer" in curbing the West African outbreak.

September 17, 2014 | Daily News

Members of the Senate health and appropriations panels raised concerns about the lack of clear coordination among the slew of federal health agencies working to address the African Ebola outbreak, while backing the Obama administration's request for an additional $88 million to bolster U.S. efforts to tamp down the public health problem.

September 17, 2014 | Daily News

HHS has issued wide-ranging guidance on ways to protect U.S. health care workers from potential Ebola exposure that suggests using respirators in certain situations -- a document that workers advocates generally praise for its intense focus on correct use of personal protective equipment (PPE).

September 12, 2014 | Daily News

House Republicans on Friday (Sept. 12) pressed the Obama administration for its assessment of U.S. hospitals and other healthcare facilities' capacity to address potential Ebola cases, including details of stockpiling and other heightened precautions that have been taken. They also asked for details on how much the federal government has spent on efforts to combat the Ebola virus and what specific emergency planning and preparedness efforts are underway to prevent a domestic outbreak.

September 02, 2014 | Daily News

HHS' Office of the Assistant Secretary for Preparedness and Response (ASPR) Tuesday (Sept. 2) contracted with Mapp Biopharmaceutical to manufacture small amounts of the company's highly watched experimental Ebola drug, Zmapp, for clinical trials. Under the 18-month $24.9 million contract, ASPR's Biomedical Advanced Research and Development Authority (BARDA) will provide subject matter expertise and technical support for manufacturing, regulatory and non clinical activities, HHS said.

August 28, 2014 | Daily News

The National Institutes of Health -- following an expedited sign off from FDA -- next week will start testing in humans a vaccine intended to prevent the Ebola virus, NIH said Thursday (Aug. 28). The NIH study, which will start at the NIH Clinical Center in Bethesda, MD, is part of a multi-pronged international study that also will be launched in the United Kingdom and West African countries in the coming months.

August 21, 2014 | Daily News

Current and former FDA officials agree that promising, yet experimental, Ebola drugs should be tested on West Africans who are infected by the deadly virus, even if that means doing so outside clinical trials. FDA's top counterterrorism official this week said the agency is able to reach out to developers in the early stages of drug development, which in some cases means developers have not sought investigational new drug applications, to discuss how FDA could help researchers test those drugs faster.

August 08, 2014 | Daily News

FDA will play a role in a new HHS working group set up to grapple with ethical issues involving how to decide who should get first dibs on experimental Ebola drugs should they become available in limited quantities. Ethics issues aside, companies won't be allowed to distribute the drugs without first getting FDA's permission via an emergency investigational new drug application, HHS noted.

August 05, 2014 | Daily News

Industry experts engaged in advanced-design textiles are urging health care providers and policymakers to support the use of fluid-repellant laboratory coats as a “first line of defense” against disease pathogen transmission in health care settings, saying such apparel amounts to an engineering control against the biological health hazards that are ubiquitous in hospitals and other facilities -- a push that occurs as the Occupational Safety and Health Administration (OSHA) reportedly moves forward internally on a rule to address infectious diseases across numerous types of work sites.

April 08, 2013 | Daily News

Stakeholders involved with medical countermeasures -- now that Congress has reauthorized key programs -- are now turning their attention to convincing lawmakers to fully fund these activities and appropriate billions of dollars in a tight budget environment.

February 13, 2013 | Daily News

The looming budget sequester, if allowed to kick in, could hinder FDA's ability to participate in an interactive review process that fosters the approval of novel vaccines, FDA's chief scientist told lawmakers at a House Energy and Commerce oversight hearing.