Transcription of ANDA Stability Guidance Opportunities & Challenges
{{id}} {{{paragraph}}}
Example: barber
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 work
ANDA Stability Guidance Opportunities & Challenges Upinder S. Atwal, Ph.D. Team Leader . OGD/CDER/FDA . GPhA/FDA CMC Workshop . June 3, 2014 . 1
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
Related search queries
Summary of Challenges and Opportunities facing, Challenges, Opportunities, Ethiopian Coffee: Challenges and Opportunities, Adult Literacy Research: Opportunities and, Adult Literacy Research: Opportunities and Challenges, GLOBAL VALUE CHAINS: CHALLENGES,, GLOBAL VALUE CHAINS: CHALLENGES, OPPORTUNITIES, AND, OECD, Study on Challenges and Opportunities in, Opportunities and challenges