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  • Regulatory NewsRegulatory News

    Update: Gottlieb Lays Out Plans to Bolster FDA's Staff

    Editor's note: This article has been updated with the number of vacancies at CDER as of 8 July 2017. Looking to fill a "substantial" number of job vacancies, the US Food and Drug Administration (FDA) will soon pilot new hiring and recruitment procedures for its drugs and biologics programs. In a blog post Monday, FDA Commissioner Scott Gottlieb said the agency has struggled to keep pace with its staffing needs as it confronts increasingly complex and specialized produ...
  • 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 NewsRegulatory News

    New Senate Bill Looks to Help FDA Attract Talent

    The Senate’s response to the House-passed 21st Century Cures bill is slowly shifting into a series of bills, the latest of which would seek to help the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) attract top new employees. Chairman of the Senate HELP Committee Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) introduced the bill, known as the FDA and NIH Workforce Authorities Modernization Act , which enables FDA t...
  • Regulatory NewsRegulatory News

    FDA Hires New Directors, Deputy Directors for Four Foreign Offices

    A big shakeup is underway at the US Food and Drug Administration's (FDA) foreign offices as four new directors and one deputy director were named to the agency's posts in China, Europe, India and Latin America. The shift to new leadership comes as the following employees have moved on: Christopher Hickey, Ph.D., (former director, China Office), Carl Sciacchitano (former acting director, India Office), Michael Rogers (former director, Latin America Office), and Bruce Ross...
  • Regulatory NewsRegulatory News

    On a Hiring Spree, FDA Hires Almost 1,000 New Generic Drug Regulators

    If you're a regulatory professional whose job includes working with the US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), you might be seeing some new names and faces in your interactions with the agency—about a thousand of them, in fact. In an update last week to FDA staff, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), said OGD had succeeded in hiring 923 new employees as of October 2014. OGD has been on a hiring...
  • Regulatory NewsRegulatory News

    FDA Looking for a Leader for its New Device Testing Division

    The US Food and Drug Administration (FDA) is on the hunt for a new leader for its device center's newly formed Division of Biology, Chemistry and Materials Science (DBCMS). The new division, housed within the Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Laboratories (OSEL), is primarily concerned with how medical devices physically interact with patients. For example, its staff will be assessing devices for biocompatibility, biolo...
  • Regulatory NewsRegulatory News

    FDA's Long, Long Search for a Chief Information Officer

    The US Food and Drug Administration (FDA) is having a difficult time finding a suitable candidate for its vacant chief information officer (CIO) position. Background FDA has been without a permanent CIO since March 2013, when Eric Perakslis, formerly of Johnson & Johnson, left the agency after just six months . The position has been filled on an acting basis since then by Walter Harris , who is also FDA's deputy commissioner for operations. As FierceBiotechIT note...
  • Regulatory NewsRegulatory News

    After FDA's Top Cop Leaves, Agency Looks for Replacement

    The US Food and Drug Administration (FDA) is looking for a new director for its Office of Criminal Investigations (OCI), it announced on Thursday. The OCI is FDA’s criminal enforcement wing, charged with going after suspected violators of the  Federal Food, Drug and Cosmetic Act . The 29 May 2014 announcement on the government's federal jobs board, USAJobs.gov, explains that the agency is looking for someone who can develop and direct its criminal investigation activi...
  • Feature ArticlesFeature Articles

    Transforming Temporary Resourcing into Strategic Resourcing

    • 26 March 2014
    Human resourcing in the pharmaceutical, device and biotech industries is characterized by tremendous upsizing and downsizing, a direct reflection of the ever-changing pace of product development. The focus everywhere is on flexibility, scalability and profitability. These conditions have led to a seismic change: from a primary dependence on long-term hiring of permanent full-time employees (FTEs) to an "on-demand" approach to human resourcing. The market has adapted to th...