Generic Drugs Forum 2016 – Files Page

Keynote: Update on GDUFA implementation Kathleen Uhl, MD	View Recording
GDUFA Regulatory Science Update Wenlei Jiang, PhD	View Recording
Fundamentals of Bioequivalence Trueman W. Sharp, MD, MPH	View Recording
How to use the Inactive Ingredient Database (IID) Susan Zuk, MS	View Recording
How an ANDA Gets Reviewed Kevin Denny, PharmD Craig Kiester, RPh, MS, RAC	View Recording
Question-based Review (QbR) in an Integrated Review Approach Damaris Maldonado, BS	View Recording
Division of Microbiology Assessment: Who we are, what we do and our recommendations to industry Lynne Ensor, PhD Pre-Approval Inspections Robert Iser, MS	View Lynn Ensor Recording View Robert Iser and Joint Q&A Recording

Overview of Controlled Correspondence Process Controlled Correspondence Marissa McNall, PharmD Content and Format for Accurate Submissions Thomas Hinchliffe, PharmD	View McNall Recording View Hinchliffe and Joint Q&A Recording
ANDA Submissions – Refuse-to-Receive and eCTD considerations Johnny Young, MA Julia Lee, PharmD	View Recording
Current Trends in Labeling and Best Practices Lillie Golson, PharmD	View Recording
Entering the Home Stretch: GDUFA I Entering its Final Year Donal Parks, MBA, MPM	View Recording
Common errors and opportunities to improve FDA submissions and communications Giuseppe Randazzo, MS Lieutenant Geoffrey Wu	View Recording