Halozyme Therapeutics Inc (HALO)

[Fred Kadiddlehopper]

Adcom Agenda 7.31.14

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm402696.htm

On the morning of July 31, 2014, the committee will meet in open session to discuss Baxter Healthcare Corporation’s biologics license application for HyQvia, Immune Globulin Infusion 10 percent (human) combined with Recombinant Human Hyaluronidase for the treatment of patients with primary immune deficiency disorders. In the afternoon, the Committee will meet in open session to discuss reentry of blood donors deferred on the basis of Chagas disease test results.

Meeting Materials
Materials for this meeting will be available at the Blood, Vaccines and Other Biologics Advisory Committee main page.
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/default.htm

Public Participation Information
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 July 24, 2014
Oral presentations on July 31, 2014 from the public will be scheduled between approximately 10:30 a.m. and 11:00 a.m. Afternoon presentations will be scheduled between approximately 3:30 p.m. and 4 p.m.
Those individuals interested in making formal oral presentations should notify the contact person 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 on or before July 16, 2014. 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 July 17, 2014.
For those unable to attend in person, the meeting will also be Web cast. The Web cast will be available at the following link.
Blood Products Advisory Committee July 31, 2014:
https://collaboration.fda.gov/bpac714/
Contact Information

Bryan Emery or Joanne Lipkind
10903 New Hampshire Ave., Bldg. 71, rm. 6132, Silver Spring, MD 20993-0002, 240-402-8054
e-mail: [e-mail] or email: [e-mail]
FDA Advisory Committee Information Line
1-800-741-8138 (301-443-0572 in the Washington, DC, area). Please call the Information Line for up-to-date information on this meeting.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. Seating for this meeting may be limited, so the public is encouraged to watch the free webcast if you are unable to attend. The link for the webcast will be available at 8 a.m. July 31, 2014 at the links above. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Bryan Emery or Pearline Muckelvene at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Official FR Notice