Transcription of ANDA Stability Guidance Opportunities & Challenges
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ANDA Stability Guidance Opportunities & Challenges
ANDA Stability Guidance Opportunities & Challenges Upinder S. Atwal, Team Leader OGD/CDER/FDA GPhA/FDA CMC Workshop June 3, 2014 1 Agenda Introduction Opportunities & Challenges Conclusions 2 Introduction Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Questions and Answers 3 Introduction contd. History of development 2011, 2012, 2013 Presentations, and in- house meetings held with stake-holders and FDA including GPhA Workshops Questions from the Industry and GPhA were collected for responses; draft Q&A Guidance was published Two webinars (DIA, and SBA) were hosted by the members of the Stability working group 4 Implementation June 20, 2014 is the implementation date The Q&A Guidance will assist in the adoption Referenced ICH Stability Guidances: Q1A(R2) Stability Testing of New Drug Substances and Products with Glossary Q1
Implementation • June 20, 2014 is the implementation date • The Q&A guidance will assist in the adoption • Referenced ICH Stability Guidances:
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