Excerpt: On June 4, 2015, the NIH Clinical Cneter suspended operations of its Pharmaceutical Development Section after the discovery of serious manufacturing problems and lack of compliance with standard operating procedures. This followed an inspection conducted by the FDA from May 19-29, 2015, which found a series of deficiencies in the PDS physical facility.
EPA’s pending rule threatens serious economic harm and is being proposed as the nation continues to face major fiscal and employment challenges, including stagnant wages and a low labor participation rate.
Excerpt: The mismatched seasonal influenza vaccine and the high death rate among the elderly and other high-risk populations in the U.S. during the 2014-2015 influenza season highlight the need for an improved response, including making seasonal influenza vaccines more effective and promptly available. We believe understanding the lessons from the 2014-2015 influenza season could improve the U.S. public health response in the future and possibly save thousands of lives.
Excerpt: Thank you for your letter of May 27, 2015, relating to the Food and Drug's Administration's (FDA or the Agency) issuance and posting of Untitled Letters. We will be happy to provide you and your staff with a briefing, as requested, and in the meantime, have provided answers to your questions below.
Excerpt: In the proposed rule, EPA seeks to impose individual CO2 mandates for each state's electricity sector, to be implemented and subject to enforcement on accelerated timelines. EPA projects this rule will result in tens of billions of dollars in compliance costs, higher electricity prices, and potential elimination of nearly 20 percent of all coal-fired generating capacity -- 46 to 49 gigawatts (GW) -- by 2020.
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