Please see the following for information about how to speak at the November 5, 2015 FDA meeting. Please contact Jennifer via the contact information listed below in order to sign up to be a speaker. Thank you to all who are willing to speak at the meeting!
On November 5, 2015, the committees will discuss the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.
Meeting  location:
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland
Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:30 p.m. on November 5, 2015. Please note that we will be accepting requests to speak at the Open Public Hearing session of this meeting through October 14, 2015. If the unusual situation arises where more people wish to speak than can be reasonably accommodated during the scheduled Open Public Hearing session, we will conduct a lottery to identify (via a random process) those who will be speaking. You/the speaker will be notified (by e-mail) on October 15, 2015 to confirm the request to speak.
In the meantime, please provide us the following information:
• Full contact information, including address
• Brief statement of the general nature of the evidence or arguments you wish to present
• Amount of time requested
• Any audio/visual requirements
• The organization(s) you will be representing, if any
Please let me know if you have any questions. Thank you for your interest in the FDA’s Antimicrobial Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee.
Kind Regards,
Jennifer Shepherd, RPh.
LCDR, USPHS
Designated Federal Officer, AMDAC, Food and Drug Administration (FDA),Center for Drug Evaluation and Research (CDER), Office of Executive Programs (OEP), Division of Advisory Committee and Consultant Management (DACCM)
White Oak Building 31, Room 2417
10903 New Hampshire Avenue
Silver Spring, MD 20993
Main Telephone: (301) 796-9001 –Â Fax: (301) 847-8533
Email: AMDAC@fda.hhs.gov
Lisa, is there any way of finding out how many have requested to speak? I hope there are way too many!
Here are my plans. If you would like to coordinate with me so that we get together and some expenses are shared, I would like that a lot. I look forward to meeting any of you who are able to go!
I’ll be flying from Denver to DC (flying into Reagan or whatever they call it) on November 4th. I’ll take the subway from the airport to my cousin’s home in Navy Yard in DC. Navy Yard is only about a mile from the capital and it’s a great location for site-seeing in DC, but it’s not particularly close to the FDA meeting in Silver Spring. If you want to stay in Navy Yard with me, there is a Marriott that is right next to my cousin’s building. You can find information about it and reserve a room at http://www.marriott.com/hotels/travel/wasny-courtyard-washington-capitol-hill-navy-yard/. If you stay there, we can share cabs to and from the meeting in Silver Spring. I plan to attend the entire meeting, as I think it’s really important. If you stay in DC we can also get together for dinner and get to know each other, which I would certainly love to do. 🙂 (But if you want to stay closer to the FDA meeting, that’s totally understandable.) I’ll probably stay in DC for a few days to visit with my cousin and see sites, then I’ll fly back to Denver.
I’m not going to make any of these plans solid until I get confirmation from Jennifer/the FDA that I am scheduled to speak at the meeting. If I can’t speak, I don’t think I’ll go.
If you want to coordinate traveling and getting together with me, please let me know.
Regards,
Lisa