CRE Requests Comments From Study Authors

May 17, 2010

In the attached letter from CRE to Dr. Hersey, CRE is asking for his views and those of his co-authors on the CRE review of the said study. CRE’s operation of an Interactive Public Docket (IPD) requires studies and their attendant reviews to be conducted in public and on the record.

CRE encourages input from the scientific community. CRE will make the appropriate modifications to its analysis, if appropriate, subsequent to receipt of the views of the authors and the public. In that the said study is one highlighted by FDA to the Advisory Committee, we welcome the input from the FDA.

We also encourage the FDA to keep the Advisory Committee aware of this review since they will be opining on this important matter.


N. B.  CRE encourages respondents to submit relevant studies. To this end studies can be attached by utilizing the “upload” function in the box to the right. If the upload function does not exist, go to “View” on this  IPD webpage, click on text size and reduce it.

The CRE letter to study authors is attached hereto.

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