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 Post subject: FDA Meeting 6/10/08 re: contact lens products post-market
PostPosted: Fri May 30, 2008 3:07 pm 

Joined: Sat Nov 26, 2005 1:23 pm
Posts: 2080
http://www.accessdata.fda.gov/scripts/c ... fm?mtg=699

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee Ophthalmic Devices Panel

Date and Time The meeting will be held on the following dates:
Jun 10, 08 8:00 AM - 4:30 PM

Location Hilton Washington DC North/Gaithersburg, Salons A, B and C
620 Perry Parkway
Gaithersburg , MD

Disability Accommodations 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 AnnMarie Williams, Conference Management staff, at 240- 276-8932, at least 7 days in advance of the meeting.

Contact Information Karen F. Warburton, Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, (240) 276-4238, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512396. Please call the Information Line for up-to-date information on this 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.

Agenda The committee will discuss general issues concerning the postmarket experience with various contact lens care products. The discussion will include recommendations on contact lens care product development topics such as preclinical testing and clinical performance measures, and labeling for contact lenses and lens care products. 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. Background material is available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link.

Procedure 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 June 5, 2008. Oral presentations from the public will be scheduled on June 10, 2008, between approximately 9:30 a.m. and 10 a.m., and between approximately 3:30 p.m. and 4 p.m. Those desiring to make 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 May 28, 2008. 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 May 29, 2008.
Persons attending FDA?s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

Conduct FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ for procedures on public conduct during advisory committee meetings.

Related Documents Other: Waivers for Conflicts of Interest for June 10, 2008 Meeting

Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato

 Post subject:
PostPosted: Fri May 30, 2008 3:58 pm 
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Joined: Fri Jan 11, 2008 10:02 pm
Posts: 72
http://www.opticianonline.net/Articles/ ... ring+.html

The agency is also inviting members of the public or interested parties to make formal statements during the hearing. The news comes at a time when B&L is facing hundreds of lawsuits connected with the recall of ReNu with MoistureLoc in 2006. The company's filing to the US Securities and Exchange Commission in October 2007 revealed that over 500 product liability suits linked to the recall had been filed against it. A total of 550 actions have been filed on behalf of individuals who claimed they suffered personal injury as a result of using the solution.

Last June, AMO recalled its Complete MoisturePlus multipurpose contact lens solution after it was linked by the US Centers for Disease Control and Preventation to a serious outbreak of corneal infections. The company is also facing several personal injury lawsuits in US courts.


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