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Public Meeting - Array-Based Cytogenetic Tests: Questions on Performance Evaluation, Result Reporting and Interpretation, June 30, 2010

Tue, 06/08/2010 - 5:36am
U.S. Food & Drug Administration

The purpose of the meeting is to seek input on challenges related to performance evaluation, determination of clinical significance, result reporting and interpretation for array-based cytogenetic tests.


Date, Time and Location

This meeting will be held June 30, 2010, beginning at 1:30 pm, at the following location:

Hyatt Regency Bethesda

7400 Wisconsin Avenue

Bethesda, MD 20814

301-657-1234

The meeting will not be videotaped or webcasted.

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Tentative Agenda

1:00 pm Registration
1:30 pm FDA Welcome
1:35 pm Background
2:00 pm Panel Discussion
4:30 pm Public Comments
5:00 pm Meeting Adjourns

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Registration to Attend the Workshop

If you wish to attend this Workshop, you must register by close of business on June 21, 2010.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you wish to make an oral presentation during the open comment session at the meeting, you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in section III of this document. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep open session focused, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.

If you need special accommodations due to a disability, or additional information regarding registration, please contact Susan Monahan, Food and Drug Administration, 10903 New Hampshire Ave, Bldg 66, Rm 4321, Silver Spring, MD 20993, 301-796-5661, e-mail: Susan.Monahan@fda.hhs.gov; or Zivana Tezak, Food and Drug Administration, 10903 New Hampshire Ave, Bldg 66, Rm 5668, Silver Spring, MD 20993, 301-796-6206, e-mail Zivana.Tezak@fda.hhs.gov at least 7 days in advance.

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Contact Us

Susan Monahan

Food and Drug Administration

10903 New Hampshire Ave, Bldg 66, Rm 4321

Silver Spring, MD 20993

Phone: 301-796-5661

e-mail: Susan.Monahan@fda.hhs.gov

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