FDA Animal Drug Users FDA to Present ADUFA III Process Enhancements Live Webinar and 60-Day NF Qualifying (A)NADA Labeling Supplements ( Q and A/submit your questions prior to the second seminar)

60-Day NF Qualifying (A)NADA Labeling Supplements

The first part of the two-part webinar series entitled “60-Day NF Qualifying (A)NADA Labeling Supplements (QLS)” provides a pre-recorded update on the ADUFA III process enhancement regarding shortened review time of 60 days for a specific subset of labeling supplements requiring pre-approval by CVM. Regulatory citations defining which supplements qualify and which do not are discussed, as are the specific requirements supporting submission of a 60-day QLS. Viewers are encouraged to also attend the second webinar (on January 26, 2015), which provides a live Q and A session to address any questions. Questions should be submitted prior to the second webinar, if available, to Linda.Wilmot@fda.hhs.gov in order to provide CVM time to adequately answer them.

Part One - https://collaboration.fda.gov/p3a1h6p24ft/

Part One Slides

Part Two - Live Q&A Session scheduled for January 26, 2015 from 12:00 pm to 1:00 pm EST.

View webinar at https://collaboration.fda.gov/cvm_qls_live_webinar/

FDA to Present ADUFA III Process Enhancements Live Webinar

November 24, 2014

The Food and Drug Administration's Center for Veterinary Medicine (CVM) announces Part Two of the “60-Day NF Qualifying (A)NADA Labeling Supplements (QLS)” webinar, featuring a live Q and A session, to take place on: Monday, January 26, 2015 from 12:00 noon to 1:00 pm. Questions should be submitted to Linda.Wilmot@fda.hhs.gov prior to the webinar so that CVM has time to adequately prepare the answers to the questions to present at the webinar.

This live Q and A follows the first webinar of the two-part webinar series. Part I, a pre-recorded update on the ADUFA III process enhancement regarding shortened review time of 60 days for a specific subset of labeling supplements requiring pre-approval by CVM, can be viewed at https://collaboration.fda.gov/p3a1h6p24ft/.

Part One is a discussion of the regulatory citations defining which supplements qualify and which do not, and the specific requirements supporting submission of a 60-day QLS.

The live webinar can be viewed at https://collaboration.fda.gov/cvm_qls_live_webinar/.
 

Additional Information

• 60-Day NF Qualifying (A)NADA Labeling Supplements