For Industry

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 an 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. On January 26, 2015, the second webinar provided a live Q and A session to address any questions.

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

Part One Slides

Part Two - Q&A Session - https://collaboration.fda.gov/p271s4umyq2/  

Page Last Updated: 11/28/2017
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