• Regulatory NewsRegulatory News

    Gottlieb Testifies on Status of FDA Operations After Government Shutdown

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb testified before the House Committee on Appropriations Wednesday on the current state of agency activities. Gottlieb expressed confidence that the agency is “back on track,” despite the 35-day lapse in FDA appropriations during the longest partial government shutdown in US history. Members of the subcommittee on agriculture, rural development, FDA and related agencies questioned Gottlieb on the status of ...
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    Update: Appropriations Bill Would Give FDA $269M Boost Over FY2018 Budget

    The House and Senate passed a seven-bill spending package on Thursday to fund large portions of the federal government through FY2019. And President Donald Trump has said he will sign the bill.   The spending package comes near the end of a three-week stopgap funding measure to allow the government to reopen after a record 35-day partial government shutdown that began on 22 December 2018 after President Donald Trump refused to sign a short-term spending bill over his...
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    New Deal to Reopen Federal Government Until Feb. 15

    The US Food and Drug Administration (FDA) and other parts of the federal government will reopen for a few weeks while border security is ironed out, according to a deal President Donald Trump announced Friday. Senate Minority Leader Chuck Schumer (D-NY) said the deal would pass both the Senate and the House on Friday and re-open the government through 15 February. And the government will be back open on Monday. Senate Majority Leader Mitch McConnell (R-KY) said in a ...
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    PDUFA Funds Likely to Run Out in February

    As the Senate preps for votes to reopen the government on Thursday, the situation at the US Food and Drug Administration (FDA) is becoming increasingly strained. At an all-staff meeting for employees of the centers for drugs and biologics on Tuesday, Commissioner Scott Gottlieb announced that Prescription Drug User Fee Act (PDUFA) funding is likely to run out by 17 February (he’d previously said it would run out by the beginning of February), although the agency may f...
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    More FDA Furloughs Expected, Gottlieb Warns

    As the government shutdown enters its second month, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and fellow leaders at the agency will be tasked with difficult decisions on who to furlough. The agency is expected to halt its review of prescription drug applications around the first week of February, and other medical products reviewed under user fee laws will follow suit in the coming months. “As our biggest user fee program, PDUFA, begins to run...
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    FDA Adds Unpaid Exceptions as the Shutdown Drags On

    As the shutdown continues in its third full week, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb took to Twitter on Sunday to reveal additional activities that are considered “excepted, unpaid work” because they are necessary to identify and respond to threats to human safety. The additional activities, which have been added after careful analysis and in close consultation with senior FDA leaders and public health experts, include: Expanded inspect...
  • Government Shutdown Leaves FDA Operating at Reduced Capacity, But User Fees Act as Agency Savior

    BOSTON - The US Food and Drug Administration (FDA) is, as of 1 October 2013, operating at just above half capacity thanks to a failure of the US Congress to pass a bill appropriating funding for the US government, agency officials said. At the Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence conference in Boston, MA, the effects of the shutdown were at least partially evident. Several agency officials, despite having already booked hotel rooms and t...
  • US Legislators Reportedly Close to Deal to Prevent Government Shutdown

    • 01 August 2012
    Numerous reports indicate US legislators are close to a deal that would temporarily avert threats of a government-wide shutdown, likely sparing federal agencies the anxiety and frustration of conducting emergency shutdown analyses and impact statements-or furloughing staff. The agreement, reportedly reached between Senate Majority Leader Harry Reid (D-NV), Speaker of the House John Boehner (R-OH) and other party leaders on both sides of the political aisle would involve ...