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FDA may also discontinue Chief Counsel review of Warning Letters

  • In 2002, FDA initiated the controversial practice of having all draft Warning Letters reviewed by the Office of the Chief Counsel (OCC)

  • FDA critics have charged that the OCC Warning Letter review has significantly reduced the number of letters

    • Number of Warning Letters has dropped by nearly 60 percent since the policy was implemented

  • The media has recently reported that FDA is re-examining the policy and may remove OCC from the review process

  • If OCC review is no longer required, industry can expect: (1) more Warning Letters, and (2) shorter timelines for WLs to be issued

© 2009 Hogan & Hartson LLP. All rights reserved.

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