FDA to Modernize Drug Review Office Structure and Processes

On June 4, 2018, Fda posted a statement from CDER Director Janet Woodcock saying a multi-pronged Fda initiative to modernize FDA’s drug evaluate places of work and processes.  The initiative will contain:

  • Staffing increases
  • Growing the variety of evaluate places of work from the current 5 to 9 and the evaluate divisions from the current 19 to 30
  • Developing a multi-disciplinary evaluate team at the outset of an software evaluate, changing the current procedure where the evaluate division consults with other Fda places of work as required during the course of a evaluate
  • Centralizing evaluate processes so that they are regular across all evaluate divisions, rather than having division-particular processes, and concentrating administrative administration in just a team of regulatory gurus
  • Developing a unified put up-market place security surveillance procedure to keep track of security each pre- and put up-approval
  • Improving the patient’s voice in drug improvement

Click on listed here for Dr. Woodcock’s statement, and listed here for a connected statement from Fda Commissioner Gottlieb.  Whilst this appears to be a significant internal initiative and reorganization, each statements contain extremely minimal element. There is only preliminary info on what the 30 evaluate divisions will be, as captured in the illustration under from a tweet Dr. Gottlieb posted on Twitter (and even the illustration appears preliminary as the Division of Professional medical Imaging is listed two times).  We’ll be monitoring this initiative and submitting more info as we acquire it.

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