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October 13, 2004
DoubleTree Hotel
Rockville , MD

The FDA Veterinary Medical Advisory Committee (VMAC) will meet to discuss the microbial food safety of an antimicrobial drug application currently under review for use in food producing animals in accordance with CVM's Guidance for Industry #152 - Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern | doc | | pdf |.

The Maryland State Board of Veterinary Medical Examiners has approved six hours of continuing education credit for this one day meeting.

The meeting will be held on October 13, 2004 , from 8:30 a.m. to 5 p.m. , at the DoubleTree Hotel, Plaza Room III, 1750 Rockville Pike, Rockville , MD , 20852 . The meeting will be open to the public.

CVM Updates

• VMAC Fall 2004 Meeting Scheduled for October 13, 2004, August 31, 2004

Federal Register Notices

• OC 2004217.  Veterinary Medicine Advisory Committee; Notice of Meeting.  Pages  53078-53079 [FR Doc. 04-19779] August 31, 2004 | htm | | pdf | Meeting on October 13, 2004

Microbial Food Safety of an Antimicrobial Drug Application

• Background Materials

  • Agenda

  • Registered Speakers (doc)

  • Framework Document

  • Guidance for Industry #152 - Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern | doc | | pdf |

  • Tulathromycin Solution for Parenteral Injection : Microbiological Effects on Bacteria of Human Health Concern - A Qualitative Risk Estimation  | doc | | pdf |

• Members and Consultants (doc)

• VMAC Questions (doc)

  • Do the findings presented in the sponsor’s (qualitative risk) assessment demonstrate that tulathromycin is safe with respect to the potential for transfer of antimicrobial resistant organisms to humans?

  • Are there other issues to consider relative to this class of antimicrobial agents (macrolides/triamilides)?

  • Other species for which it should/should not be approved?

    • Routes of administration that are/are not acceptable?

    • Indications that are/are not appropriate? 

    • Other relevant issues?

  • Are the risk management recommendations appropriate, or should they be modified?

• Presentations

• VMAC Fall 2004 Meeting Transcript (doc)

• VMAC Fall 2004 Summary

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