SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

Generic Drugs Forum 2016 – Files Page

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April 13:

Keynote: Update on GDUFA implementation
Kathleen Uhl, MD
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GDUFA Regulatory Science Update
Wenlei Jiang, PhD
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Fundamentals of Bioequivalence
Trueman W. Sharp, MD, MPH

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How to use the Inactive Ingredient Database (IID)
Susan Zuk, MS
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How an ANDA Gets Reviewed
Kevin Denny, PharmD
Craig Kiester, RPh, MS, RAC
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Question-based Review (QbR) in an Integrated Review Approach
Damaris Maldonado, BS
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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

April 14:

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
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Current Trends in Labeling and Best Practices
Lillie Golson, PharmD
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Entering the Home Stretch: GDUFA I Entering its Final Year
Donal Parks, MBA, MPM
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Common errors and opportunities to improve FDA submissions and communications
Giuseppe Randazzo, MS
Lieutenant Geoffrey Wu
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