Dear Advisory Committee participant:
Thank you for your
participation in our upcoming meeting of the Anti-infective Drugs Advisory
committee (AIDAC) on
As noted in the introduction section on page 2 of the attached briefing document, AIDAC members previously discussed the CRBSI in 1999 and a draft guidance was issued (enclosed). We now look forward to your continued support and advice towards resolution of problems encountered by sponsors related to the current guidance, in addition to discussion of the PBSA indication and the PBSI clinical trials.
Please review the five attached documents listed below and bring these to our upcoming meeting.
Developing Antimicrobial Drugs for Treatment
Please note that as the FDA briefing document has not been circulated to the public, it can only be reviewed by you and kept securely and confidential- not for view by the general public until the day of our upcoming meeting.
I hope that you have all
received your travel documents. For those of you who are attending the
Veterinary Medicine Advisory Committee meeting on
Please do not hesitate to contact me if you have not received your travel documents (air itinerary, hotel information, etc.) and I will be happy to provide assistance to you regarding these issues and/or any other questions you may have. I look forward to meeting each of you in October.
Health Science Administrator
Food and Drug Administration
P (301) 827-6759
F (301) 827-6776