• 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

    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...
  • 11 New Consumer Advocates to Join Advisory Committees in 2013

    The US Food and Drug Administration (FDA) is calling for the nomination of consumer representatives for its public advisory committees. FDA uses the advisory panels to review high-risk drug products or pressing issues that warrant a transparent discussion of the issues and allow for public comment. Though regulators are free to disregard the final opinions of the committee-and occasionally do, most often when the panel is deeply divided-the committees' opinions often for...
  • FDA Calls for Nominations as 11 Spots Open on Four Advisory Committees

    US regulators are calling for the nomination of new members of several prominent advisory committees it uses to formulate non-binding but influential recommendations. The committees often serve as a pre-review stage for new or controversial products, and the views of its committee members regularly act as a barometer for safety, efficacy and quality concerns. In a Federal Register notice released 4 October, the US Food and Drug Administration (FDA) said it is aw...