July 23, 2012: FDA-TRACK CVM Quarterly Briefing Summary

Sign up to receive FDA-TRACK email updates

 

CVM Administrative Dashboard – Office of the Center Director (OCD) and Office of Management (OM)

• CVM had an additional meeting required under ADUFA II section 104 that states “not less frequently than once every 4 months during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of veterinary, patient, and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes” in ADUFA III.  In addition, ADUFA III negotiation meetings with Industry took longer than originally anticipated – four meetings were added to the negotiation schedule. Therefore, OM had to revise the milestone due dates for the “Pioneer and Generic Drug User Fees Renegotiations” key project to reflect the changes.

CVM Office of Research (OR)

• OR completed the main phases of the bridging studies for ceftiofur and tetracycline as part of its key project, “Updating Obsolete Regulatory Residue Methods”. This project will provide more rapid and reliable methods to detect unsafe veterinary drug residues in animal-derived food products. 

 

CVM Office of Surveillance and Compliance (OSC)

• OSC completed its “Medically Necessary Veterinary Product (MNVP)” key project to strengthen MNVP tools, resources and strategies to proactively address drug shortages. The MNVP Program focuses on shortages of medically necessary products used to treat a serious or life threatening disease, as well as those shortages that would have the greatest impact on public health.

 

CVM Premarket Dashboard – Office of Minor Use and Minor Species (OMUMS) and Office of New Animal Drug Evaluation (ONADE)

• ONADE did not complete one generic investigational new animal drug (JINAD) submission consisting of protocols without substantial data on time in June 2012 due to a miscoded protocol. However, ONADE continues to exceed all Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA) performance goals tracked via FDA-TRACK in FY12 year-to-date.