Workshop
Event Title
Advancing Generic Drug Development: Translating Science to Approval
September 21 - 22, 2021
- Date:
- September 21 - 22, 2021
- Day1:
- - ET
- Day2:
- - ET
Topics & Presentations |
Speakers |
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Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency Alternative Bioequivalence Approaches for Data Analysis Due to COVID-19 Related Study Interruptions Quality Considerations in the Development of FDA Guidance “Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency” Applications and Lessons Learned for Conducting Adaptive Designs on Generic Drug Development Q&A Panel
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Mitchell Frost, MD Yuqing Gong, PhD Gloria Huang, PhD Kairui (Kevin) Feng, PhD Kimberly Witzmann, MD Stella C. Grosser, PhD |
Advancement in the In-Vitro Evaluation of Abuse-Deterrent Formulations for Opioid Analgesics: Research and Assessment Perspectives Physiological Based Pharmacokinetic Modeling and Simulation Absorption Modeling and Virtual Bioequivalence to Support Generic Drug Development and Regulatory Decision Making for Oral Products Safety Assessment of Flavors in Generic Drug Products Q&A Panel
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Saeid Raofi, MS Manar Al-Ghabeish, PhD Fang Wu, PhD Melanie Mueller, PharmD, PhD Xiaoming Xu, PhD Heather Boyce, PhD
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Advances in Iron Colloid Products: Product-Specific Guidance (PSG) Discussion Advances in Iron Colloid Products: Quality Considerations When Conducting Comparability Studies Injectable Suspensions: Tools and Methods Bridging the In Vivo and In Vitro Gap Q&A Panel
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Wenlei Jiang, PhD Yiwei Li, PhD Bin Qin, PhD Bruce Lerman, PhD Darby Kozak, PhD
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Challenges in the Approval of Complex Otic and Ophthalmic Generic Products: Bioequivalence Perspectives Challenges in the Approval of Complex Otic & Ophthalmic Generic Products: Quality Perspectives Physiological Based Pharmacokinetic Modeling and Simulation to Support Generic Ophthalmic Drug Product Development and Regulatory Decision Making Q&A Panel
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Chunsheng Zhao, PhD Poonam Chopra, PhD Poonam Chopra, PhD Yan Wang, PhD Asif Rasheed, PhD Kai Kwok, PhD
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Advancing Generic Drug Development: Translation Science to Approval, Day One Closing Remarks
|
Lei Zhang, PhD |
Cutting Edge Science in Complex Generics Utility of Artificial Intelligence to Facilitate the Development and Regulatory Assessment of Complex Generic Drugs Model-Integrated Evidence for Bioequivalence Assessment of Complex Generic Drugs Scanning Electron Cryomicroscopy (Cryosem) for Characterization of Complex Drug Products Advanced Imaging and Data Analysis to Support Compositional Structure Similarity of Polymeric Formulations Q&A Panel
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Meng Hu, PhD Miyoung Yoon, PhD Huzeyfe Yilmaz, PhD Yan Wang, PhD Robert Lionberger, PhD Daniel Willett, PhD
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Complex Generics_Nasal and Inhalation Products Product-Specific Considerations for Alternative Bioequivalence (BE) Approaches to Comparative Clinical Endpoint BE Studies Approaches for studies interrupted due to COVID-19 for Nasal and Inhalation Products Demonstrating Bioequivalence with Inhalation Spray Drug Products Comparative Analyses for Generic Oral Inhalers Q&A Panel
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Susan Boc, PhD Vipra Kundoor, PhD Sneha Dhapare, PhD Michael Spagnola, MD Bryan Newman, PhD Changning Guo, PhD Bing Cai, PhD
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Complex Generics_Topical Products, Part 1 “No Difference” Standard vs. Q1|Q2 Sameness for Topical Drug Products Use of Q3 Characterization Tests for Topical Semisolid Drug Products Recent Research Related to Q3 Characterization of Topical Products Containing Porous Microparticles Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products Q&A Panel
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Megan Kelchen, PhD Sam Raney, PhD Ahmed Zidan, PhD Eleftheria Tsakalozou, PhD Khondoker Alam, PhD Markham Luke, MD, PhD
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Complex Generics_Topical Products, Part 2 Common Issues Identified in In-vitro Release Test (IVRT) and In-vitro Permeation Test (IVPT) Studies Submitted in ANDA to Support Bioequivalence for Topical Products Theoretical Principles and Best Practices: In Vitro Release Test Theoretical Principles and Best Practices: In Vitro Permeation Test Q&A Panel
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Josephine Aimiuwu, PhD Tannaz Ramezanli, PhD, PharmD Priyanka Ghosh, PhD Markham Luke, MD, PhD Sam Raney, PhD
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Advancing Generic Drug Development: Translation Science to Approval, Day Two Closing Remarks
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Robert Lionberger, PhD |
Agenda
View the updated agenda
KEYNOTE SPEAKER
Janet Woodcock M.D.
Acting Commissioner of Food and Drugs
Food and Drug Administration
The purpose of the public workshop is to communicate how outcomes from FDA research conducted under the Generic Drug User Fee Amendments (GDUFA) guide and facilitate generic drug development, regulatory assessment, and approval. The workshop will focus on common issues seen in Abbreviated New Drug Applications (ANDAs), link GDUFA science and research on complex products and scientific issues to product-specific guidance development and pre-ANDA meeting discussions, and examine various areas of the science and cutting-edge methodologies behind generic drug development.
This workshop is part of the SBIA Regulatory Education for Industry (REdI) series and is being offered as part of FDA’s Drug Competition Action Plan, which aims to increase competition and make it easier and more efficient for drug developers to bring more generics into the marketplace, while maintaining FDA’s high standards for quality and scientific rigor.
Topics
Sessions and topics will be divided across different product types and key topics present in today’s environment.
Sessions will cover the following products and topics:
- COVID-19 Impact on Generic Drug Regulation and Evaluation
- Assessing Generic Drug Products of Oral Dosage Forms
- Complex Generics: Complex Injectables, Ophthalmic and Otic Products
- Cutting-Edge Science in Complex Generics
- Complex Generics: Nasal and Inhalation Products
- Complex Generics: Topical Products
Learning Objectives
- Apply various mechanisms and processes that industry can use to obtain advice from FDA to facilitate generic drug development.
- Comprehend new developments in science, guidance, and review experience for specific types of generic drug products.
Intended Audience
Scientists, researchers and regulatory affairs professionals who work on or are interested in working on the development of generic drugs including complex generic products that are more challenging to develop.
FDA Resources
- Generic Drugs
- Generic Drug Science & Research
- Generic Drug Development
- Product-Specific Guidances for Generic Drug Development
CDER Small Business & Industry Assistance (SBIA)
For more comprehensive resources for information on human drug development in regulation, visit CDER Small Business and Education.