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Daily Archives: April 22, 2008

New GAO Report: FDA Initiatives and Drug Safety

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Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have Potential, but Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program, GAO-08-701T, April 22, 2008.

  • “Recent FDA initiatives – some of which have been implemented and others proposed – could strengthen FDA’s foreign drug inspection program, but these initiatives do not fully address the weaknesses that GAO previously identified. GAO testified in November 2007 that FDA’s databases do not provide an accurate count of foreign establishments subject to inspection and do provide widely divergent counts. Through one recent initiative, FDA has taken steps to improve its database intended to include foreign establishments registered to market drugs in the United States. This initiative may reduce inaccuracies in FDA’s count of foreign establishments. However, these steps will not prevent foreign establishments that do not manufacture drugs for the U.S. market from erroneously registering with FDA. Further, to reduce duplication in its import database, FDA has supported a proposal that would change the data it receives on products entering the United States. However, the implementation of this proposal is not certain and would require action from multiple federal agencies, in addition to FDA. Efforts to integrate these databases have the potential to provide FDA with a more accurate count of establishments subject to inspection, but it is too early to tell.”
  • Related postings on FDA and drug safety

    • DHS Proposes Biometric Airport, Seaport Exit Procedures

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    News release: “The U.S. Department of Homeland Security (DHS) announced today a notice of proposed rulemaking that will establish biometric exit procedures at all U.S air and sea ports of departure. The majority of non-U.S. citizens are already required to submit digital fingerprints and a digital photograph for admission into the country. The US-VISIT Exit… Continue Reading

    CBO Cost Estimate for Medicaid Safety Net Act of 2008

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    H.R. 5613, Protecting the Medicaid Safety Net Act of 2008, April 22, 2008: “Cost estimate for the bill as ordered reported by the House Committee on Energy and Commerce on April 16, 2008.” “H.R. 5613 would extend existing moratoria on certain regulatory actions taken by the Centers for Medicare & Medicaid Services (CMS) with regard… Continue Reading

    DOT Proposes 25 Percent Increase in Fuel Efficiency Standards Over 5 Years for Passenger Vehicles, Light Trucks

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    News release: “Fuel efficiency standards for both passenger vehicles and light trucks would increase by 4.5 percent per year over the five-year period ending in 2015 – a 25 percent total improvement that exceeds the 3.3 percent baseline proposed by Congress last year – under an ambitious new proposal announced today by U.S. Transportation Secretary… Continue Reading

    FCC Chairman Testify and Lawrence Lessig Testify on Future of the Internet

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    Written Statement of Kevin J. Martin, Chairman Federal Communications Commission Before the United States Senate Committee on Commerce, Science and Transportation hearing, Future of the Internet, April 22, 2008. “Thank you for inviting me here today to provide my thoughts on the future of the Internet and the Commission’s current role on some of the… Continue Reading

    World Food Programme says high food prices a silent tsunami, affecting every continent

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    News release: “The World Food Programme (WFP) has said that high food prices are creating the biggest challenge that WFP has faced in its 45-year history, a silent tsunami threatening to plunge more than 100 million people on every continent into hunger.” WPF: Soaring food prices are affecting millions of people across the world –… Continue Reading

    Link Between Ozone Pollution and Premature Death Confirmed

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    News release: “Short-term exposure to current levels of ozone in many areas is likely to contribute to premature deaths, says a new National Research Council report, which adds that the evidence is strong enough that the U.S. Environmental Protection Agency should include ozone-related mortality in health-benefit analyses related to future ozone standards. The committee that… Continue Reading

    DOT: Trains Transporting the Most Toxic Hazardous Materials Must Use Safest, Most Secure Route

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    DOT news release: “Railroads will be required to route every train carrying the most toxic and dangerous hazardous materials on the safest and most secure route under a new federal rule announced today by U.S. Secretary of Transportation Mary E. Peters…beginning June 1, the rule requires railroads to conduct a comprehensive safety and security risk… Continue Reading