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FDA List Serve - CCR5 antagonist meeting postponed   Message List  
Reply | Forward Message #762 of 1137 |

You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

To UNSUBSCRIBE from this list, to change your e-mail address, or to subscribe, please go to http://list.nih.gov/cgi-bin/wa?SUBED1=fda-hiv-aids&A=1

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_______________________________________________

      After reviewing the current CCR5 antagonist development issue, the FDA CCR5 Antagonist Review Group and the Forum for Collaborative HIV Research have decided to postpone the meeting to discuss the long-term follow up of patients enrolled in CCR5 antagonist clinical trials until February or March of 2006.

      The original January 18th date was chosen to address the long-term follow up issues in as timely a manner as possible. However, because additional clinical trial data is accumulating, waiting until as much information as possible is available will ensure that the public discussion is as effective as possible.

      An announcement will be sent once the exact meeting date is established.  

      We still encourage input from the patient and advocacy communities and academia to ensure your suggestions and concerns are taken into consideration as we prepare for this important meeting. 

      Please use the website  at
      http://www.hivforum.org/CCR5/index.html to provide input.  Please provide your comments by January 15, 2006. 

      Richard Klein
      Office of Special Health Issues
      Food and Drug Administration

      Kimberly Struble
      Division of Antiviral Drug Products
      Food and Drug Administration

      An archive of past list serve announcements is available on the FDA web site at http://www.fda.gov/oashi/aids/listserve/archive.html



Thu Dec 1, 2005 8:51 pm

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Dec 1, 2005
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