March 17, 2010: Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement
|CDER||March 17, 2010
||7:30 a.m. - 3:00 p.m.
||Atlanta Marriott Marquis
265 Peachtree Center Avenue
Atlanta, Georgia 30303
Telephone: (404) 521-0000
On March 17, 2010, the Committee will discuss and provide comments on the following topics: (1) General scientific issues related to the application of pharmacogenomics in the early stages of drug development. Pharmacogenomics examines the genetic differences that influence a person’s responses, both beneficial and harmful, to certain drugs; (2) a new patient-centric clinical pharmacology approach to drug safety; (3) the design and analysis of clinical pharmacology studies focusing on how the renal function changes in the way the body absorbs, distributes, metabolizes and excretes a drug in patients with kidney impairment; (4) scientific considerations and recent developments in transporter-mediated drug interactions. These interactions are between two or more drugs that either inhibit or enhance the roles of specialized proteins known as “transporters” and, in turn, the interactions can affect a drug’s safety and/or efficacy.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. There are two options for written submissions for this meeting: 1) to the Division of Dockets Management or 2) to the contact person for this meeting as described below.
- Comments may be submitted to the Division of Dockets Management. Electronic comments may be submitted to the Division of Dockets Management at: regulations.gov. 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. Submit a single copy of electronic comments or two paper copies of any mailed documents, except that individuals may submit one paper copy. Comments should be identified with the docket number for this meeting [Docket No. FDA–2010–N–0067]. Comments received to the docket on or before March 8, 2010, will be provided to the committee before the meeting. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m. Monday through Friday.
- Written submissions may be made to the contact person on or before March 8, 2010
- Oral presentations from the public will be scheduled between approximately 9:25 a.m. and 10 a.m. and 1:15 p.m. and 1:45 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 March 1, 2010.
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 March 2, 2010.
- Yvette Waples
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
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
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 Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the 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.
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Please visit our Web site Public Conduct During FDA Advisory Committee Meetings 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).