GDUFA Research Outcomes
Other Generics Research
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to other research relevant to generic products.
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ICH M13A: First ICH Guideline for Bioequivalence
Zhang, Lei K
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Introduction & Overview: Current Regulatory Horizon of Narrow Therapeutic Index Drugs & ICH Guideline Development for Bioequivalence Assessment
Zhang, Lei
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Opening Remarks – Global Bioequivalence Harmonization: Enhancing Access to Affordable Medicines
Zhang, Lei
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FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Drug Products
Zhang, Lei K
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FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Drug Products
Zhang, Lei
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A Deep Dive: GDUFA III Scientific Meetings Introduction
Zhang, Lei
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Regulatory Science to Support Global Harmonization for Establishing BE for Generic Oral Products
Zhang, Lei
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ICH M13 Guideline Series
Zhang, Lei
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Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”
Zhang, Lei; Tampal, Nilufer; Kim, Myong Jin
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Identify Research Needs and PSG Development for Complex Products
Xu, Xiaoming