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Emergency Response

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.

February 13, 2013 | Daily News

Sources expect a bill reauthorizing HHS medical countermeasure programs to easily move through both chambers of Congress now that a consensus has been reached between the House and Senate.

January 23, 2013 | Daily News

Stakeholders who support the Pandemic and All-Hazards Preparedness Reauthorization Act hope passage of the bill by the House Tuesday (Jan. 22) and a growing chorus urging completion of work on the measure could compel senators to abandon efforts to attach a federal drug track and trace system, allowing PAHPA to move swiftly through the upper chamber.

January 18, 2013 | Daily News

FDA's recent approval of an anthrax antitoxin -- the first new chemical entity to be approved under a rule allowing companies to test for efficacy using animal models -- shows the agency is making progress in its efforts to improve regulatory science, and the approval could provide a pathway for other companies developing medical countermeasures, sources said. However, one source cautioned that other products, such as vaccines, could be more difficult to assess using such models.

December 19, 2012 | Daily News

The House on Wednesday (Dec. 19) passed a bill forged by House and Senate leaders to reauthorize HHS medical countermeasure programs, but the compromise legislation, which has the support of Senate health committee leadership, could face opposition from some members in the upper chamber because it fails to include a White House-backed strategic investor program or a federal drug track and trace system.

June 21, 2012 | Daily News

BOSTON -- HHS' move this week to set up three public-private centers to develop and manufacture medical countermeasures is viewed as a dramatic step forward by the administration to combat past challenges in development of medical countermeasures, including those for the H1N1 flu vaccine.

December 14, 2011 | Daily News

An Obama administration plan to support start-up companies in developing and manufacturing medical countermeasures is part of a bipartisan bill passed out of the Senate health committee Wednesday reauthorizing HHS medical countermeasures programs. The so-called Strategic Investor initiative was not included in the House-passed version, and the White House last week urged the Senate to add the program when it took up the legislation.

December 07, 2011 | Daily News

The White House praised House lawmakers for passing Tuesday (Dec.6) bipartisan legislation reauthorizing HHS medical countermeasures programs, but urged the Senate to strengthen the bill by authorizing a “strategic investor” effort to further boost industry investment. The Strategic Investor program, a key administration initiative, would aid start-up companies in developing medical countermeasures.

November 21, 2011 | Daily News

Senate legislation reauthorizing HHS medical countermeasures programs would expand emergency use authorization, establish a process for FDA to consider animal models, and ensure the agency is involved earlier in the development process for these medications, garnering praise from a key biotechnology industry group and other stakeholders.

November 15, 2011 | Daily News

Congressional conferees agreed to raise FDA's budget by $50 million over last year's level as part of a fiscal 2012 conference report released late Monday night that says the increase will help the agency implement the food safety law and work on new medical countermeasures. The conferees also direct FDA to publish a proposed rule revising the monograph regulating the labeling of over-the-counter cough and cold products for children by Dec. 31.

October 28, 2011 | Daily News

A program manager at the Pentagon's Defense Advanced Research Projects Agency said industry needs to stop blocking the government from using their diagnostic devices for medical countermeasure research, saying companies must remove financial and intellectual property barriers.

October 25, 2011 | Daily News

A proposal from public health advocates to allocate money for health departments to tap into electronic health records for surveillance purposes has caught the attention of a key lawmaker, as the Obama administration feels pressure to add public health reporting to health information technology meaningful use requirements.

October 19, 2011 | Daily News

The Obama administration considers the upcoming reauthorization of the Pandemic and All-Hazards Preparedness Act as a viable vehicle to establish a proposed program to support start-up companies in developing and manufacturing medical countermeasures, a top HHS official said at a Senate hearing Tuesday (Oct. 18).

October 06, 2011 | Daily News

The Obama administration should cease pursing development of an FDA-approved kit containing antibiotics for use in an anthrax attack because these so-called MedKits are too costly and pose a safety risk, according to a new report from the Institute of Medicine released Friday (Sept. 30). The kits have only been tested in pilot settings, according to an author of the report, as the federal government eyes funding development of these products for distribution to the general population.

October 04, 2011 | Daily News

The federal government's biomedical countermeasure research agency is diversifying its portfolio of anthrax products to get closer to developing a useable next-generation vaccine, but availability of the drug is unlikely to occur any time soon, the director of the agency told FDA Week following the recent announcement of two new contracts for a vaccine and antitoxin against the bacteria.

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