FY 2019 Generic Drug Regulatory Science Initiatives Public Workshop May 1, 2019

Workshop | In Person

• Date: May 1, 2019
• Location: Food and Drug Administration; White Oak Campus ; 10903 New Hampshire Ave; Silver Spring, MD 20993; United States

• Organized By: Office of Generic Drugs

Background:

FDA will hold a public workshop that will provide an overview of the current status of the regulatory science initiatives for generic drugs and will provide an opportunity for public input on research priorities in these topic areas. FDA is seeking input from a variety of stakeholders––industry, academia, patient advocates, professional societies, and other interested parties––as it fulfills its commitment under the reauthorization of the Generic Drug User Fee Amendments (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing the fiscal year (FY) 2020 Regulatory Science Plan.
 
The workshop will be held on May 1, 2019, at the FDA White Oak Campus, 10903 New Hampshire Avenue Building 31, Great Room Sections B & C, Silver Spring, MD 20993.

FDA wants your input. You may submit ideas on generic drug research topics to be included on the FY 2020 Regulatory Science Plan by emailing GDUFARegulatoryScience@fda.hhs.gov.

Workshop Recordings:

• Part 1: https://collaboration.fda.gov/pq9lc8pxuznk/ 

• Part 2: https://collaboration.fda.gov/pbhtfiqnhbxp/

• Part 3: https://collaboration.fda.gov/pvuv6hwanizw/

• Part 4: https://collaboration.fda.gov/pkts2nc4snky/

• Part 5: https://collaboration.fda.gov/pdglplr18z74/

Presentations:

Session I: Implementation of FY 19 Generic Drug Research Priorities

• FY 2019 GDUFA Regulatory Science Initiatives Public Workshop - Robert Lionberger, ORS/OGD/CDER/FDA
• Impact of Excipients on BCS Class 3 Drug Product Dissolution and Permeability - Sid Bhoopathy, Absorption Systems 
• BCS Class 3 Waivers: Expansions Beyond Q1/Q2 - Siva Vaithiyalingam, Regulatory Affairs North America, Cipla 
• Predicting Food Effect: Applications in Clinical Drug Development -Arian Emami Riedmaier, Abbvie
• An Industry Perspective on Successful Prediction of Food Effect and Fed BE Studies - Amitava Mitra, Sandoz
• Reducing the Burden of Proof – Re-evaluating the Necessity of Fed Bioequivalence Studies - Gregg DeRosa, Teva
• Scientific Gaps that Impact the Prediction of Fed BE Studies -Zhanglin Ni, ORS/OGD/CDER/FDA
• Advantages and Challenges in Implementing New Analytical Methods that Arise from Regulatory Science Initiatives - Darby Kozack, ORS/OGD/CDER/FDA
• Challenges for Industry in Implementing New Computational Methods that Arise from Regulatory Science Initiatives - Liang Zhao, DQMM/ORS/OGD/CDER/FDA

Session II: New drug approvals that pose scientific challenges to generic product development

• Newly Approved Complex Drug Products and Potential Challenges to Generic Drug Development - Lei Zhang, ORS/OGD/CDER/FDA
• Development of Enhanced Analytical Tools for Evaluation of Complex Generic Products - Jason Rodriguez, OTR/OPQ/CDER/FDA

Session III: Considerations for Future Regulatory Science Initiatives

• Specific Challenges in the Evaluation of Irritation and Sensitization for Transdermal Systems: A Dermatological Appraisal Focusing on Scoring and Application - Walter Wigger-Alberti, Bioskin GmbH
• Challenges Faced in the Development of the User Interface for Generic and Biosimilar Combination Products - Lisa Nilsson, Teva
• A Potential Role for Innovative Bayesian and PBPK Approaches to Generic Drug Development -Joga Gobburu, University of Maryland
• Demonstrating US Reference Standard and Foreign Reference Standards Sameness - Kiaran Krishnan, Apotex

Public Comment Presentations

• Studies to further establish PK as central tool for a streamlined approval of generic inhalation drugs - Jürgen Bulitta and Günther Hochhaus, University of Florida
• Assessing excipient solutions for generic drug development -Priscilla Zawislak, International Pharmaceutical Excipients Council Foundation
• Non-Biological Complex Drugs Challenges for approval standards - Vinod P. Shah, Non-Biological Complex Drug Working Group
• Integrated Approach for Product Bioequivalence of Complex Ophthalmics - Vatsala Naageshwaran, Absorption System
• Introduction of Assurance Case Method and its Application in Regulatory Science - Fubin Wu, Gessnet Risk Management

FR Notice: Fiscal Year 2019 Generic Drug Regulatory Science Initiatives; Public Workshop; Request for Comments

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Event Materials

Title	File Type/Size
Final Agenda	pdf (38.91 KB)
Panel List	pdf (60.95 KB)
May 1 2019 Generic Drug Workshop - Final Transcript	pdf (1.33 MB)