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Emergency Response

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.

July 26, 2011 | Daily News

The full House Energy and Commerce Committee intends to mark up legislation Thursday (July 28) that would reauthorize HHS medical countermeasure programs and mandate more structured coordination between FDA and sponsors of these products, Rep. Joe Pitts (R-PA), chair of the panels health subcommittee, told FDA Week. The Energy and Commerce health subpanel marked up and favorably reported the legislation Tuesday (July 26), slightly modifying the measure via a managers package.

July 25, 2011 | Daily News

The House Energy and Commerce Committee health subpanel will mark-up legislation on Tuesday (July 26) to reauthorize HHS medical countermeasures programs, with the measure already being considered as a major hook for lawmakers' pet issues, including Democrats' attempt to boost funding for FDA's regulatory science program by stripping money from procurement.

July 01, 2011 | Daily News

The House Energy and Commerce Committee is set to consider later this month legislation introduced Wednesday (June 29) to reauthorize HHS medical countermeasure development programs also includes provisions that would expand the role of FDA in the arena and require the agency to prioritize products that protect against chemical and biological attacks, drawing praise from a key biotechnology industry group.

June 27, 2011 | Daily News

Drug industry stakeholders contend FDA lacks comprehensive guidance and has a dearth of expertise on using alternative technologies for influenza vaccines, resulting in hindered development of these products, according to a Government Accountability Office report released Monday (June 27). FDA responded that it intends to strengthen staff expertise, while noting that guidance documents cannot cover all possible scenarios, therefore instead the agency intends to regularly meet with manufacturers.

March 22, 2011 | Daily News

Existing FDA authorities granted through a 2002 bioterrorism law, existing nuclear detection infrastructure and procedures and guidance implemented after the 1986 Chernobyl nuclear accident are enabling FDA to track, identify and isolate cargo from Japan that could be contaminated with radiation in the wake of the tsunami and earthquake that damaged the Fukushima nuclear reactor, agency and industry sources said.

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