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  • Regulatory NewsRegulatory News

    FDA Details Plans for More Efficient Inspections, Facility Evaluations

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) will soon launch an effort to streamline the two offices' inspection and facility evaluation efforts. In an email to FDA staff on Monday, CDER Director Janet Woodcock and Associate Commissioner for Regulatory Affairs Melinda Plaisier said it is vital that the two offices quickly implement the plan in order to meet commitments under the recent...
  • Regulatory NewsRegulatory News

    FDA Announces Major Regulatory Changes, With Specialization a Key Focus

    Regulatory functions at the US Food and Drug Administration (FDA) are set to undergo a major overhaul in the coming months after a year-long effort by the agency recommended making scores of improvements to the way the agency is structured and regulates products. Background In September 2013, FDA announced to internal staff that, in response to "unparalleled challenges" posed by advances in product complexity and globalization, FDA would be forming a new "Program Alignm...
  • Woodcock Announces New Leader for CDER Compliance Office

    One of FDA's top pharmaceutical regulatory officials is getting a promotion. In an email sent to staff on Wednesday, 28 November, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), announced the promotion of Howard Sklamberg, JD, to the position of director of CDER's Office of Compliance (OC). Sklamberg will assume the OC position on 14 January 2013, Woodcock wrote. He currently serves as deputy associate commissioner for regulatory affair...
  • 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 ...
  • FDA Releases Strategic Plan for Veterinary Medicine Program

    The US Food and Drug Administration (FDA) has released a new strategic plan for its veterinary medicine program for the 2012-2016 period, outlining the regulatory goals for FDA's Center for Veterinary Medicine. The plan, intertwined with FDA's plan for the Center for Food Safety and Applied Nutrition (CFSAN), provides seven "strategic program goals" and dozens of specific initiatives meant to carry out those strategic program goals. FDA's Foods and Veterinary Medicine...