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U.S. Department of Health and Human Services

Advisory Committees

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September 17, 2014 Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement

CenterDateTimeLocation
CDERSeptember 17, 20148:00 a.m. to 5:00 p.m.College Park Marriott Hotel and
Conference Center
3501 University Blvd. East
Hyattsville, Maryland

Agenda

The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.
 
Meeting Materials
 
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 Materials 

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 September 3, 2014.
  • Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m. on September 17, 2014.  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 August 25, 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 August 26, 2014.

 

Webcast Information

CDER does not provide webcasts of advisory committee meetings that are held at venues other than the FDA White Oak Conference Center.  Therefore, CDER will not be providing a webcast of the meeting.

 
Contact Information

Kalyani Bhatt, BS, MS
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD  20993-0002

Phone: 301-796-9001
Fax: 301-847-8533
Email: BRUDAC@fda.hhs.gov

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.
 
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 FDA Advisory Committee Information 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.  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 Moon Hee V. Choi at (301) 796-9001 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 at 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).