CVM\'s New Animal Drugs for Use in Feeds Workshop
Sponsored by the American Academy of Pharmacology and Therapeutics
Register at aavpt.org 2013 Biennial Symposium — (see register link in top, right corner)
The workshop begins at 1 pm on Wednesday May 22, 2013 through Thursday May 23, 2013 at noon. Workshop follows the AAVPT’s 18th Biennial Symposium, Bolger Center.
Wednesday, May 22, 2013 AFTERNOON
1:00-1:10 PM | Workshop Introduction B. Dunham |
1:10-1:30 PM | Center for Veterinary Medicine – Organization and Structure S. Modric |
1:30-1:55 PM | New Animal Drugs for Use in Animal Feeds: Types and Categories D. Momcilovic |
1:55-2:15 PM | Development and Approval of Labeling for Medicated Feeds S. Sechen |
2:15-2:30 PM | Where to Find Approved Labeling for Medicated Feeds D. Momcilovic, S. Sechen |
2:30-2:55 PM | Proposed changes to the Veterinary Feed Directive Regulations J. Gulley, S. Benz |
2:55-3:15 PM | BREAK |
3:15-3:45 PM | Antimicrobial Drugs in Animal Feeds: Update on FDA\\\'s Judicious Use Strategy C. Lewis |
3:45-4:05 PM | Understanding ADAA Combinations D. Benz |
4:05-4:20 PM | Generic Approval Process and Biowaiver Requirements C. Long |
4:20-5:00 PM | Round Table Discussion Q & A |
Thursday, May 23, 2013 MORNING
8:00-8:20 AM | Biomass Drug Substances A. Simms |
8:20-8:50 AM | Type A Medicated Articles and CMC Issues J. Nitao |
8:50-9:20 AM | CMC Data to Support Medicated Feeds H. Longstaff |
9:20-9:45 AM | Medicated Feed Assay Methods and Limits: Regulatory Perspective A. Rasheed |
9:45-10:00 AM | CMC Q &A |
10:00-10:15 AM | BREAK |
10:15-10:40 AM | What do Feed Mill Inspections Have to do with Drug Approvals? S. Jordre |
10:40-11:10 AM | Interactions with CVM P. Duquette, K. Baker, C. Herr |
11:10-11:40 AM | Round Table/Q & A |
11:40-12:00 PM | Wrap Up & Next Steps |