FDA Hepatitis C Public Hearing on Study Design Issues for New Hep C Drugs

[Guest guest]

FDA Hepatitis C Public Hearing on Study Design Issues for New Hep C

Drugs

The Food and Drug Administration (FDA) will hold a public meeting of

its Antiviral Drugs Advisory Committee on October 19 and 20, 2006,to

discuss design issues in the development of products for treatment

of chronic Hepatitis C, including co-infection with HIV.

The meeting will be held on October 19, 2006, from 8 a.m. to 4 p.m.

and on October 20, 2006, from 8 a.m. to 4 p.m. at the Hilton

Washington DC/Silver Spring, 8727 Colesville Rd., Silver Spring, MD,

20910 in The Ballrooms. Please note that meeting will be closed to

the public on October 20 from 1 p.m. to 4 p.m., to permit discussion

and review of trade secret and/or confidential information.

On both days, the committee will discuss clinical trial design

issues in the development of products for the treatment of chronic

hepatitis C infection. This meeting is being convened in response to

the growing number of products in development for this indication.

The primary objectives for committee deliberations are to discuss

issues related to the identification of appropriate control arms,

populations for study, endpoints, and long-term follow-up. As noted

above, on October 20, 2006, the meeting will be open to the public

from 8 a.m. to 12 noon, unless public participation does not last

that long, and closed to the public from 1 - 4 p.m.

Background material will become available no later than 1 business

day before the meeting and will be posted on FDA's Web site at

http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?

from=leavingFR.html & log=linklog & to=http://www.fda.gov/ohrms/dockets/a

c/acmenu.htm. (Click on the year " 2006 " and scroll down to the

Antiviral Drugs Advisory Committee meeting.)

Interested parties may submit comments electronically on line at

http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?

from=leavingFR.html & log=linklog & to=http://www.fda.gov/dockets/ecommen

ts. Select " 2006N-0219--Clinical Trial " and follow the prompts to

submit your statement.

Written comments may be submitted to the Division of Dockets

Management (HFA-305), Food and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852, by close of business on October

5, 2006.

All comments received will be posted without change, including any

personal information provided. Comments received on or before

October 5, 2006, will be provided to committee members before the

meeting.

Oral presentations from the public (the open public hearing section

of the meeting) will be scheduled between approximately 1 p.m. and 2

p.m. on October 19, 2006. Time allotted for each presentation may be

limited depending on the number of requests to speak. Those desiring

to make formal oral presentations should notify the contact person

(below) on or before October 5, 2006, and submit a brief statement

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

present, the name(s) and contact information of the proposed speaker

(s), and an indication of the approximate time requested to make

their presentation.

Contact Person: Cicely Reese, Center for Drug Evaluation and

Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,

(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD

20857, 301-827-7001, FAX: 301-827-6776, e-mail:

cicely.reese@...

For up-to-date information about the meeting, please use the FDA

Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in

the Washington, DC area), and enter code no. 3014512531.

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 Cicely Reese at

least 7 days in advance of the meeting.

No registration is necessary.

Persons attending FDA's advisory committee meetings are advised that

the agency is not responsible for providing access to electrical

outlets.

If you need hotel accommodations or directions, please contact the

hotel directly at 301-589-5200.

Klein

Office of Special Health Issues

Food and Drug Administration

Struble

Division of Antiviral Drug Products

Food and Drug Administration