The 2008 Animal Drug User Fee Act (ADUFA) authorizes FDA to collect fees for certain animal drug applications, which support the agency’s responsibilities to ensure that new animal drug products are safe and effective for animals as well as for the public.
ADUFA is due for reauthorization this year, and FDA’s Center for Veterinary Medicine (CVM) aims to educate stakeholders on data submissions under the act. CVM plans two webinars on the topic, scheduled for June 4 and 6, 2013. According to CVM, the sessions will be of interest to anyone who thinks about or touches upon target animal safety or effectiveness data submitted to FDA/CVM. The webinars will provide participants with insights and considerations in critical areas related to data collection where improvements would be most effective.
There is no formal registration for the webinars, which will take place from 9:00 a.m. to 12:00 noon on both days. FDA has not yet released the webinar agenda or URL and instructions for access, but will provide those details at least one week before the webinar on the CVM website.
Webinar presentation materials, audio transcripts of the presentations, and a written transcript of questions and answers will be made available on CVM’s website within 30 days after the webinar.