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Workshop on Factor VIII Inhibitors - Stakeholders

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Dear Factor VIII Inhibitor Workshop Stakeholder:

At the November 21, 2003 FDA/IABs Factor VIII Inhibitor Workshop there was insufficient time available for full discussion of the many important topics that were covered at that meeting. We announced at the end of the Workshop that we would accept written comments on the Workshop for a limited time. Subsequently, several participants sent their comments to us for our consideration.

Many expressed a desire to convey comments but wanted more time to prepare their remarks. Accordingly, Federal Docket number 2004N-0033 has been assigned to receive submissions of comments, critiques of others' comments, or new information that you would like to make about topics covered at the Factor VIII Inhibitor Workshop.

For those of you who have already submitted written information to us, we invite you to re-submit these same comments to the Federal Docket for general consideration. You have the option of revising or extending your remarks if you wish, or may re-submit the material that you have already provided to us.

Submit comments on the Factor VIII Inhibitor Workshop, docket number 2004N-0033, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm, or by e-mail to FDADOCKETS@oc.fda.gov.

The Docket will remain open for at least one year from its announcement in the Federal Register, which we anticipate will occur in the near future.

Sincerely,

Jay Lozier, M.D., Ph.D.
FDA Center for Biologics Evaluation and Research
Office of Blood Research and Review
Division of Hematology
Laboratory of Hemostasis
301-496-1225
301-402-2780 (FAX)
lozier@cber.fda.gov

 

 
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