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  • Regulatory NewsRegulatory News

    EMA Preps for Staff Shortages, Possible 'Major' Budget Deficit

    Although the new European Medicines Agency's (EMA) location will not be known until November, EMA on Friday said again that it's anticipating heavy staff losses which will not only challenge its operability but "could also result in a major deficit in its budget," according to highlights published Friday from a management board meeting this month. The comments follow the agency saying last week that it could lose between 19% and 94% of its staff depending on whic...
  • 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

    CDRH Seeks Participants for Staff Training Program

    Medical device companies and other stakeholders have until 30 April to apply to be a part of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP), which is meant to help agency staffers better understand medical devices.  The training program, which is not intended for FDA to inspect, assess, judge, or perform a regulatory function (e.g., compliance inspection), is "is intended to provide CDRH ...
  • 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...
  • CDRH Publishes List of Projects and Guidance Documents Planned for 2013 Completion

    It's that time of year-the holidays, yes, but also when companies and agencies are putting the final touches on their planning documents for 2013. The US Food and Drug Administration (FDA) is no exception to this trend, and its Center for Devices and Radiological Health (CDRH) has just published its 2013 Strategic Priorities plan. Calling the plan a continuation and expansion of its efforts to promote "smart regulation," CDRH said it is reorganizing its plan to better ...
  • Report Claims Staffing Problems Continue to Plague FDA

    The reputation of a federal agency often precedes it. For the US Food and Drug Administration (FDA), the public's perception of its reputation is proving to be a significant impediment to its attempts to recruit the best regulatory staff it can get, says a new report from the Partnership for Public Service (PPS). The group acts as a sort of advocacy group for those working in, or hoping to work in, the government. PPS said it had recently been approached by the Pew Cha...
  • Legislators Slam DHHS, FDA for Special Hiring Practices

    The US Food and Drug Administration (FDA) has increased its use of special hiring authorities more than 50% in recent years to bring on staff members who can be paid more than the normal limit for federal employees, and some legislators are none too pleased at the trend. In a 14 September 2012 hearing, the Government Accountability Office (GAO), which earlier released a report on the topic , testified that the Department of Health and Human Services' (DHHS) use of speci...
  • Top FDA Regulatory Official Stepping Down, Will Assume New Duties

    The US Food and Drug Administration's (FDA) top regulatory affairs official, Dara Corrigan, is giving up her duties and assuming a position as director of FDA's Europe Office and as senior advisor for global operations, sources tell Regulatory Focus . Corrigan had served as the associate commissioner for regulatory affairs since September 2010, where she was in charge of more than 4,000 staff focused on ensuring regulatory compliance in import, export and manufacturing ...
  • CDER Provides Guidance to FDA Staff on How to Expedite Review of ANDA Supplements

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has issued a new Manual of Policies and Procedures (MAPP) document in which the agency describes to internal staff the guidelines for expediting the review of Abbreviated New Drug Application (ANDA) supplements. FDA's 5240.1: Requests for Expedited Review of Supplements to Approved ANDAs , posted  27 April, describes how ANDA supplement sponsors "may ask FDA to expedite ...
  • Health Canada, Facing Budget Cuts, Lays off Hundreds of Employees

    Health Canada is facing the prospect of dire budget cuts after national austerity measures called for more than $5.2 billion to be cut from the Canadian federal budget, reports The Globe and Mail . Health Canada is facing a budget shortfall of $200 million per year, and notified its staff in early April that it may need to lay off approximately 840 staff to close the gap. Those staff reductions have reportedly already started, with notifications going out to 715 Health...
  • New FDA Standard on Cargo Theft Released

    The US Food and Drug Administration (FDA) released a new standard operating procedure (SOP) for staff outlining how FDA responds to cargo thefts. The 23 March SOP, FDA'S Response to Cargo Thefts , intends to "provide a general procedure for determining FDA's regulatory response when a cargo theft involving an FDA-regulated product has occurred," writes FDA. "FDA is very concerned about the increase in cargo and warehouse thefts of FDA regulated products, including pres...
  • BMJ: Despite Warning, FDA Approved Higher-Dose Aricept

    An article in The British Medical Journal ( BMJ) claims the US Food and Drug Administration (FDA) approved a higher-dose version of Eisai's blockbuster Alzheimer's drug Aricept 23 (donepezil) despite the concerns of its reviewers at FDA, reports The New York Times . FDA review staff noted their concerns about the drug's safety and efficacy, according to  The Times, finding little evidence of the drug's effectiveness in a 1,400-person clinical trial, but finding...