Questions - 2004 VMAC

1. 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?
   
2. 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?
     

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