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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EU Committee Slams Plan to Cut EMA Staffing Ahead of Brexit (7 September 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU Committee Slams Plan to Cut EMA Staffing as Agency Prepares for Brexit A health committee has criticized plans to cut staffing levels at the European Medicines Agency (EMA) next year. The Committee on the Environment, Public Health and Food Safety (ENVI) said it “strongly disapproves” of the European Union’s proposal to reduce the number of EMA positions authorized ...
  • Regulatory NewsRegulatory News

    Senate Democrats to Trump: HHS Cuts Will Impede 'Cures' Implementation

    Eleven Senate democrats sent a letter to President Donald Trump on Tuesday explaining how his proposed cuts in the FY 2018 budget for the Department of Health and Human Services (HHS) will make implementation of the bipartisan 21st Century Cures Act much more difficult. "We urge you to listen to both sides of the aisle and drop any attempts to implement the damaging proposed cuts at HHS laid out in your budget," they wrote. Trump’s budget blueprint for 2018 ...
  • White House Jumps to Defense of FDA, Other Agencies, over Proposed Budget Cuts

    White House officials are backing up a number of allegations made by several industry watchers regarding the effects of budget sequestration on the US Food and Drug Administration (FDA), noting that, among other things, the cuts could negatively impact drug review times and regulatory science. On 1 March 2013, federal agencies are scheduled to run into the effects of budget sequestration, which calls for annualized budget cuts of approximately 8% for all domestic non-def...
  • More than $110 Million in FDA User Fees to be Seized Under Sequestration

    The US Food and Drug Administration (FDA) stands to lose more than $300 million in funding and industry-paid user fees under a budget sequestration process scheduled to come into effect in January 2013, according to a new report released by the Office of Management and Budget. The report, " OMB Report Pursuant to the Sequestration Transparency Act (STA) of 2012 ," came in response to legislators' demands that the executive branch release more information regarding th...
  • FDA: Budget Sequestration Could Lead to 'Loss of Whole User Fee Programs'

    The current congressional budget environment is leading to a situation in which the US Food and Drug Administration (FDA) could face the loss of "whole user fee programs" and hundreds of millions of dollars, FDA recently told Bloomberg Businessweek . The agency remarks were in response to recent reports indicating that industry-paid user fees set to flow to the agency under the recently passed FDA Safety and Innovation Act (FDASIA) legislation are at risk of bei...
  • FDA Could Soon Have Better Information to Plan for Massive Budget Cuts

    Officials at the US Food and Drug Administration (FDA) may soon have a better sense of the impact of an upcoming budget sequestration measure thanks to a new piece of legislation signed into law 7 August by President Barack Obama. The bill, the Sequestration Transparency Act of 2012 , comes as partisan wrangling over the impact of the Budget Control Act of 2011 comes to a head. The act was the culmination of a tense budget standoff between congressional Demo...
  • OMB to Federal Agencies: Begin Planning for Massive Budget Cuts

    The White House Office of Management and Budget (OMB) wants federal agencies, including the US Food and Drug Administration (FDA), to remember that on 1 January 2013, all agencies may lose nearly a tenth of their appropriated budget unless Congress acts to override a budget trigger passed into law in 2011. The 2011 action, known as the Budget Control Act (BCA) of 2011 , instituted a trigger procedure known as budget sequestration. Under the procedure, if Congress is...