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 – Fax: (301) 847-8533
Email: AMDAC@fda.hhs.gov

 

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