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  • Regulatory NewsRegulatory News

    FDA and Pentagon Forge Breakthrough Designation Agreement

    Following the Pentagon’s criticism of the US Food and Drug Administration’s (FDA) sluggishness in approving a French freeze-dried plasma product, which some have said other countries’ troops have used for years, FDA and the Department of Defense’s (DoD) Office of Health Affairs on Tuesday launched a joint program to prioritize the efficient development of such medical products. The framework for the program was established, via H.R.4374 , after DoD sought to crea...
  • Regulatory NewsRegulatory News

    Internal HHS Memo: Some FDA Employees Will be Exempt From Trump Hiring Freeze

    An internal memo from the Department of Health and Human Services (HHS) obtained by Focus on Thursday reveals that a number of positions at the US Food and Drug Administration (FDA), particularly within the Office of New Drugs, will likely be exempt from President Donald Trump’s federal hiring freeze. The memo , sent from Colleen Barros, acting deputy secretary at HHS, to staff division heads and operations division heads on 6 February, notes that HHS has a resp...
  • Regulatory NewsRegulatory News

    Hiring Freeze at FDA: Upton and DeGette Say it Puts Priorities at Risk

    Hampering the US Food and Drug Administration’s (FDA) ability to hire puts bipartisan priorities at risk, Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) wrote in a letter sent Tuesday to the acting director of the Office of Management and Budget (OMB). The letter comes as President Donald Trump in late January ordered a freeze on all government hiring, which has some exemptions for public health, though it’s unknown how the freeze impacts FDA or user fee funding to h...
  • Regulatory NewsRegulatory News

    ‘Two Out, One In’: Trump Signs Executive Order to Repeal Regulations

    President Donald Trump on Monday signed an executive order (EO) that would require all government agencies to eliminate two regulations for every new regulation instituted. The order , which White House officials characterized as a “one in, two out” plan to benefit small businesses, will likely impact the US Food and Drug Administration (FDA) as it applies to every agency but those related to military or national security-related branches of the federal government or ot...
  • Regulatory NewsRegulatory News

    FDA Staff Shortages May Get Worse With Trump’s Federal Hiring Freeze

    On Monday, President Donald Trump signed an executive order to freeze all federal government hiring and with the US Food and Drug Administration (FDA) lacking almost 1,000 employees, the freeze could further slow new drug, medical device and generic drug approvals. What’s unclear right now is whether the order, which stipulates that the “head of any executive department or agency may exempt from the hiring freeze any positions that it deems necessary to meet national s...
  • Regulatory Moratorium Bill Passes House

    The US House of Representatives passed a bill that would freeze many regulations, including those introduced by the US Food and Drug Administration (FDA), until unemployment falls to pre-recession levels. The legislation, the Regulatory Freeze for Jobs Act , was introduced in the House in February and passed the House in a 240-178 vote largely on party lines on 26 July. Among the bill's numerous provisions is a title stripping federal agencies of their power to pas...
  • Major Regulatory Changes Proposed in House Bill

    The House of Representatives is scheduled to vote on a piece of proposed legislation next week that would overhaul vast sections of the federal regulatory process. Importantly, the bill would also freeze all major regulatory activities-including many mandated by the recently-passed Food and Drug Administration Safety and Innovation Act -until the national unemployment rate falls below 6.0%. Stopping all 'Significant' Regulatory Actions The Regulatory Freeze for Job...
  • Proposed Regulatory Freeze Advances in US House

    • 21 March 2012
    A bill that would freeze many regulatory actions advanced in the House Judiciary Committee this week, bringing it one step closer to passage. The Regulatory Freeze for Jobs Act of 2012 was first introduced to the House of Representatives on 17 February, and first reported by Regulatory Focus on 27 February . The proposed legislation would prevent many regulatory actions from being passed by federal agencies until unemployment falls below 6%, including: any regulat...
  • Bill Would Freeze Major Regulatory Actions Until Unemployment Rate Falls

    • 27 February 2012
    A bill introduced in the US House of Representatives 17 February aims to halt the passage of any regulations that have economic costs of more than $100 million until the unemployment rate falls below 6%. The Regulatory Freeze for Jobs Act of 2012 (HR 4078) would also prevent any regulatory actions that creates inconsistencies with another agency, "raise novel legal or policy issues", or "materially alter the budgetary impact of entitlement, grants, user fees or loa...