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| Name of Committee | Dental Products Panel |
| Date and Time | The meeting was held on the following dates:
Sep 6, 06 8:00 AM - 5:00 PM
Sep 7, 06 8:00 AM - 5:00 PM
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| Location | Holiday Inn, Walker/Whetstone Rooms
Two Montgomery Village Ave.
Gaithersburg
, MD |
| Contact Information | Michael E. Adjodha, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283, ext. 123, email: Michael.adjodha@fda.hhs.gov or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572) in the Washington, DC area), code 3014512518. Please call the Information Line for up-to-date information on this meeting. |
| Agenda | This meeting is a joint meeting of CDRH’s Dental Products Panel and CDER’s Peripheral and Central Nervous System Drugs Advisory Committee to review and discuss peer-reviewed scientific literature on dental amalgam devices. Dental amalgam, also called “encapsulated amalgam,” consists of dental mercury and amalgam alloys. The joint committee will review and discuss peer-reviewed scientific literature on dental amalgam and its potential mercury toxicity, specifically, as it relates to neurotoxic effects. Certain consumer groups have raised concerns about the effects of using mercury as a component of dental restorative materials; therefore, we are combining the expertise of the Dental Products Panel of the Medical Device Advisory Committee with the neurology expertise of the Peripheral and Central Nervous System Drugs Advisory Committee. |
| 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 by August 23, 2006. On September 6 and September 7, 2006, oral presentations from the public will be scheduled at the beginning of committee deliberations and near the end of the deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should submit written notification to the contact person by August 23, 2006, and include the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation, and a brief statement of the general nature of the evidence or arguments they wish to present. |
| | 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 |
| Agenda: | Final Agenda |  |
| Brief Summary: | Brief Summary |  |
| Briefing: | Briefing Information | |
| Minutes: | September 7, 2006 Meeting | |
| Minutes: | September 6, 2006 Meeting | |
| Other: | Nature and Basis Statements of Conflict(s) of Interest | |
| Questions: | Final Questions | |
| Roster: | Final Roster | |
| Slides: | Slides for September 6, 2006 Meeting | |
| Slides: | Slides for September 7, 2006 Meeting | |
| Transcript: | September 6, 2006 Meeting (Pages 1 - 100) | |
| Transcript: | September 6, 2006 Meeting (Pages 101 - 200) | |
| Transcript: | September 6, 2006 Meeting (Pages 201 - 334) | |
| Transcript: | September 7, 2006 Meeting (Pages 1 - 100) | |
| Transcript: | September 7, 2006 Meeting (Pages 101 - 200) | |
| Transcript: | September 7, 2006 Meeting (Pages 201 - 315) | |
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| Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). |
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