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
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