FDA Hepatitis Update

[Guest guest]

FDA hepatitis electronic list serve. The purpose of the list serve is to relay

important information about viral hepatitis-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.

Please do not reply to this message.

FDA will be holding a meeting of its Blood Products Advisory Committee on April

28, 2011 from 8:30 a.m. to 1:00 p.m. on April 29, 2011 to discuss testing

donations of Source Plasma for hepatitis B virus infection by nucleic acid

testing. The meeting will be held at the Hilton Washington DC/North, 620

Parkway, Gaithersburg, MD.

Background materials for this meeting will be available on the 2011 Meeting

Materials, Blood Products Advisory Committee page.

Interested persons may present data, information, or views, orally or in

writing, on issues pending before the committee.

* Written submissions may be made to the contact person on or before April 13,

2011

* Oral presentations from the public will be scheduled between approximately

11:00 a.m. and 11:30 a.m.

Those individuals interested in making formal oral presentations should notify

the contact person (below) on or before April 5, 2011, and submit a brief

statement of the general nature of the evidence or arguments they wish to

present, the names and addresses of proposed participants, and an indication of

the approximate time requested to make their presentation.

Time allotted for each presentation may be limited. If the number of registrants

requesting to speak is greater than can be reasonably accommodated during the

scheduled open public hearing session, FDA may conduct a lottery to determine

the speakers for the scheduled open public hearing session. The contact person

will notify interested persons regarding their request to speak by April 6,

2011.

Contact:

* Emery or nna Harvey

1401 Rockville Pike, HFM-71, Rockville, MD 20852

301-827-1277

FAX: 301-827-0294

e-mail: .Emery@... or email: nna.Harvey@...

* Use the FDA Advisory Committee Information Line for up-to-date information on

this meeting.

1-800-741-8138 (301-443-0572 in the Washington, DC, area)

code 3014512391.

This meeting is open to the public, and there is no cost or registration

required.

There is additional information available about the meeting.

Klein

Office of Special Health Issues

Food and Drug Administration

Struble

Division of Antiviral Drug Products

Food and Drug Administration

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