Transcription of ANDA Stability Guidance Opportunities & Challenges
{{id}} {{{paragraph}}}
Example: dental hygienist
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 adoptio
ANDA Stability Guidance Opportunities & Challenges Upinder S. Atwal, Ph.D. Team Leader . OGD/CDER/FDA . GPhA/FDA CMC Workshop . June 3, 2014 . 1
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
Related search queries
Q5C Stability testing of Biotechnological /, Q5C - Stability testing of Biotechnological / Biological, Stability, Matrixing Designs for Stability Testing, BRACKETING AND MATRIXING DESIGNS FOR, BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING, Stability Workshpo ICH Q1D C, Guideline, Stability Testing, On stability testing for applications for, IPEC Stability