December 15, 2011

 

 FDA hosting webinar for AVMA members on unapproved drugs

posted November 30, 2011

The Food and Drug Administration's Center for Veterinary Medicine has arranged a webinar for Thursday, Jan. 26, about the use of unapproved animal drugs and the agency's current activities to address this area.

The FDA has been concerned that safety and effectiveness have not been demonstrated for animal drug products marketed in the U.S. without approval or other legal marketing status. In the Dec. 20, 2010, Federal Register, the agency solicited stakeholders to comment on approaches for increasing the number of legally marketed animal drug products and on the use of enforcement discretion for some unapproved animal drug products in limited circumstances. The AVMA commended the FDA on this pursuit and suggested ways to address the issue.

The webinar, "What You Need to Know: FDA-Approved vs. Unapproved Animal Drugs," is scheduled for 11 a.m. to noon EST.

The 45-minute presentation by Dr. Elizabeth Luddy, Dr. Neal Bataller, and Janice Steinschneider will be followed by a 15-minute session during which the CVM will answer questions submitted prior to the webinar. Questions may be emailed until Jan. 12 to AskCVM@fda.hhs.gov.

The agency will make available 1,000 lines for AVMA member veterinarians to listen to the webinar live, on a first-come, first-served basis. To access the "CVM/AVMA Conference—January 26, 2012" go to https://collaboration.fda.gov/cvm_avma/.

Instead of listening to the webinar online, up to 100 AVMA members can call in to the webinar toll free at (866) 556-9888, using access code 4582566.

The webinar will be archived at www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement under "Unapproved Animal Drugs." The AVMA website will provide a link.