FDA and the Center for Research on Complex Generics (CRCG) hosted a public training on May 10, 2023: Drug-Device Combination Products 101: Identifying, Developing, and Evaluating Drug-Device Combination Products
Training Date and Time:
May 10, 2023; 8:30 a.m. – 6:00 p.m.
About the Event:
Complex generic drug-device combination products are typically difficult to develop, which means that many of these products face less competition than non-complex products, and therefore can be more expensive and less accessible to the patients who need them. FDA and the Center for Research on Complex Generics (CRCG) are offering a training, Drug-Device Combination Products 101: Identifying, Developing, and Evaluating Drug-Device Combination Products, to support the efficient development of complex generic drug-device combination products and to discuss ways to enhance the quality of ANDA submissions for these products.
The purpose of this training is to describe FDA’s regulatory expectations and practices for pre-ANDA assessment and ANDA review of generic drug-device combination products, especially those with complex device constituent parts. For these products, ANDAs should include comparative analyses between the device user interfaces of the proposed generic product and its reference listed drug (RLD) as well as data supporting the quality and performance of the overall product. As the complexity of drug-device combination products increases, challenges with product development and demonstration of substitutability may also increase.
Hybrid Experience:
The training will offer both in-person and remote attendance options first four sessions. The training will be held at the Universities at Shady Grove in Rockville, Maryland.
The training will also include an interactive fifth session for in-person attendees only that will allow participants to apply the learnings from the first four sessions to a mock generic drug-device combination product development process. The fifth session will offer opportunities to handle and manipulate a variety of relevant devices.
During the training, FDA, CRCG, and generic drug industry experts will share information about:
- combination product classification
- challenges with device development and comparative user interface assessment
- methods for evaluating whether differences in the user interface may increase risks for user errors compared to the RLD when generic substitution occurs, and
- demonstration of product quality and performance
FDA and the Center for Research on Complex Generics—which is a collaboration between the University of Maryland School of Pharmacy and the University of Michigan College of Pharmacy—are dedicated to advancing programs that stimulate scientific dialogue, disseminate current insights about complex generics, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines.
Learning Objectives:
- Define drug-device combination products and discuss the drug-device combination product classification process
- Discuss how human factors should inform user interface development
- Identify generic drug industry challenges and obstacles that impact various aspects of complex generic drug-device combination product development and management across the product lifecycle.
- Review best practices for comparative analyses between the device user interfaces for a proposed generic combination product and its RLD
- Discuss when comparative analyses may be sufficient to justify user interface differences between a proposed generic and RLD and when additional data and/or information may be needed.
- Review best practices for comparative use human factor study design, execution, and reporting and discuss FDA research on other types of studies that could provide data to support user interface differences.
- Discuss GDUFA-funded research efforts to address scientific challenges and gaps that hinder development and assessment of complex generic drug-device combination products
- Discuss product quality and performance considerations for complex generic drug-device combination products such as prefilled injection pens, transdermal systems, intravaginal systems, implants, and intrauterine systems.
- Discuss pre-ANDA interactions with FDA and how to leverage these opportunities to enhance ANDA submission quality for complex generic drug-device combination products
Audience:
This training is primarily suggested for the generic drug industry and other involved collaborators, including consultants and contract research organizations that support generic drug applications.
Training Recordings:
Training Outline:
Welcome
James Polli, PhD, Co‐Director, CRCG
Course Introduction
Robert Lionberger, PhD, Director, ORS, OGD, FDA
SESSION 1: How to Identify Products That Are Drug-Device Combination Products: a CDER Product Jurisdiction and Office of Combination Products Perspective
This session will provide an overview of the regulatory framework that defines combination products that include drug and device constituent parts. Other topics will include exploring the differences between single entity, co-packaged, and cross-labeled drug-device combination products.
Introduction to Session 1
Kimberly Witzmann, MD, Deputy Director, OSCE, OGD, FDA
Definition of a Combination Product and the Complementary and Collaborative Roles of FDA’s Office of Combination Products & CDER’s Product Jurisdiction Office Have on Classifying Products as Drugs, Devices, or Drug‐Device Combination Products
Ifeanyi U. Uwemedimo, PhD, Senior Scientific Reviewer, OCP, OCPP, OC, FDA
Kristina Lauritsen, PhD, Combination Product Policy Advisor, PJO, OGD, FDA
Challenges in Drug‐Device Combination Products – Industry Perspective
Tzach Bachar, MS, Director, Regulatory Affairs, Padagis Israel Pharmaceuticals Ltd
Q&A Session with Panel
- Moderator: Kimberly Witzmann, MD, Deputy Director, OSCE, OGD, FDA
- Panelists:
Ifeanyi U. Uwemedimo, PhD, Senior Scientific Reviewer, OCP, OCPP, OC, FDA
Kristina Lauritsen, PhD, Combination Product Policy Advisor, PJO, OGD, FDA
Tzach Bachar, MS, Director, Regulatory Affairs, Padagis Israel Pharmaceuticals Ltd
Lisa Bercu, JD, Regulatory Counsel, DPD, OGDP, OGD, FDA
John Barlow Weiner, Esq, JD, Associate Director for Policy, OC, OCPP, OCPR, FDA
Brandon Wood, BS, Director, Regulatory Affairs, Gx Steriles, Teva Pharmaceuticals USA, Inc.
SESSION 2: Drug-Device Combination Products and Comparative Analyses: Best Practices Prior to and For ANDA Submission
This session will discuss the iterative role of human factors and risk assessment in device development or selection, and the use of comparative analyses to evaluate user interface differences between a proposed generic combination product and its RLD.
Introduction to Session 2
Kathryn Hartka, PharmD, PhD, Pharmacologist, Device Evaluation Team, DTP‐I, ORS, OGD, FDA
Pre‐ANDA Program Support of Generic Drug‐Device Combination Product Development
Kathryn Hartka, PharmD, PhD, Pharmacologist, Device Evaluation Team, DTP‐I, ORS, OGD, FDA
Best Practices for ANDA Submission of Comparative Analyses for Drug‐Device Combination Products & the ANDA User Interface Assessment Process
Mary Lee, MD, Senior Physician, DCR, OSCE, OGD, FDA
Challenges and Learnings with Device Development and Comparative User Interface Assessment for DDCP
Satyashodhan Patil, BE, PGDIBO, Deputy General Manager (R&D), Device Development, Sun Pharmaceutical Industries Limited
Presentation with animations (PDF)
Q&A Session with Panel
- Moderator: Kathryn Hartka, PharmD, PhD, Pharmacologist, Device Evaluation Team, DTP‐I, ORS, OGD, FDA
- Panelists:
Mary Lee, MD, Senior Physician, DCR, OSCE, OGD, FDA
Satyashodhan Patil, BE, PGDIBO, Deputy General Manager (R&D), Device Development, Sun Pharmaceutical
Industries Limited
Katharine B. Feibus, MD, Team Leader, Device Evaluation Team (Team D), DTP‐I, ORS, OGD, FDA
CDR Andrew Fine, PharmD, BCPS, Senior Advisor, DCR, OGD, OSCE, FDA
Markham Luke, MD, PhD, FAAD, Director, DTP‐I, ORS, OGD, FDA
Kimberly Witzmann, MD, Deputy Director, OSCE, OGD, FDA
Ed Stanley, PEng, Manager of R&D QA Compliance and Combination Products, Apotex Inc.
SESSION 3: Other Design Differences: Justifying Differences in User Interface That May Impact an External Critical Design
Attribute
During comparative analyses for a proposed drug‐device combination product, a generic drug manufacturer identifies user interface differences that may affect one or more critical user tasks. What are the roles of device redesign and additional information or data, such as those from comparative use human factors studies? How will OGD‐funded research contribute to identifying other types of information or data that could support certain types of user interface differences?
Introduction to Session 3
Katharine B. Feibus, MD, Team Leader, Device Evaluation Team (Team D), DTP‐I, ORS, OGD, FDA
Best Practices for Comparative Use Human Factors Study Design, Execution, and Reporting
Jason Flint, MBA, PMP, Associate Director of Human Factors, DMEPA‐I, OMEPRM, OSE, FDA
Research Efforts to Broaden Published Data on User Interface Differences & the Impact on User Error to Support Certain Types of User Interface Differences
Katharine B. Feibus, MD, Team Leader, Device Evaluation Team (Team D), DTP‐I, ORS, OGD, FDA
A Generic Drug Industry Perspective: Obstacles & Challenges in Device User Interface Design
Claire McDiarmid, MS, Senior Director, Global Device Development, Viatris, Inc.
Q&A Session with Panel
- Moderator: Katharine B. Feibus, MD, Team Leader, Device Evaluation Team (Team D), DTP‐I, ORS, OGD, FDA
- Panelists:
Jason Flint, MBA, PMP, Associate Director of Human Factors, DMEPA‐I, OMEPRM, OSE, FDA
Claire McDiarmid, MS, Senior Director, Viatris Global Development, Viatris, Inc.
CAPT Irene Z. Chan, PharmD, Deputy Director, OMEPRM, OSE, FDA
Somesh Chattopadhyay, PhD, Lead Mathematical Statistician, DB‐VIII, OB, OTS, FDA
William Chong, MD, Director, OSCE, OGD, FDA
Markham Luke, MD, PhD, FAAD, Director, DTP‐I, ORS, OGD, FDA
Nitesh Patel, MPharm, Senior Manager‐Regulatory and Business Continuity, Sun Pharmaceutical Industries Limited
SESSION 4: Drug-Device Combination and Design Differences Related to Quality and Performance
This session will discuss scientific and regulatory considerations, challenges, and best practices related to the quality and performance of generic drug-device combination products and product design differences.
Introduction to Session 4
Jamie Michalek, PhD, Senior Pharmaceutical Quality Assessor, DLBP‐II, OLDP, OPQ, FDA
Current Regulatory Perspective for Demonstrating the Quality and Performance of Proposed Generic Versions of Transdermal Systems, Intravaginal Systems, Implants, and Intrauterine Systems
Meenal Chavan, PhD, Senior Pharmaceutical Quality Assessor, DIMRP‐III, OLDP, OPQ, FDA
Lessons Learned & Best Practices for Demonstrating the Quality and Performance of Proposed Generic Versions of Injectable Combination Products
CAPT. Alan Stevens, MEng, Assistant Director, DHT‐IIIC, OHT‐III, OPEQ, CDRH, FDA
A Generic Drug Industry Perspective: Industry’s Challenges with Device Development and Demonstration of Quality and Performance of Generic Drug‐Device Combination Products
Rakesh Khilwani, PhD, Principal Device Development Engineer, Teva Pharmaceuticals USA Inc.
Q&A Session with Panel
- Moderator: Jamie Michalek, PhD, Senior Pharmaceutical Quality Assessor, DLBP‐II, OLDP, OPQ, FDA
- Panelists:
Meenal Chavan, PhD, Senior Pharmaceutical Quality Assessor, DIMRP‐III, OLDP, OPQ, FDA
CAPT. Alan Stevens, MEng, Assistant Director, DHT‐IIIC, OHT‐III, OPEQ, CDRH, FDA
Rakesh Khilwani, PhD, Principal Device Development Engineer, Teva Pharmaceuticals USA, Inc.
Robert Berendt, PhD, Branch Chief, DIMRP‐III, OLDP, OPQ, FDA
Ashley Boam, MSBE, Director, OPPQ, OPQ, FDA
Monica Garcia, PhD, Assistant Director, THT‐IIIB1, DHT‐IIIB, OHT‐III, OPEQ, CDRH, FDA
Yili Li, PhD, Senior Pharmaceutical Quality Assessor, OLDP, OPQ, FDA
Ripen Misri, PhD, Director, Co‐Development, Global R&D, Apotex, Inc.
Summary of Sessions & Closing Comments for Online Attendees
Markham Luke, MD, PhD, FAAD, Director, DTP‐I, ORS, OGD, FDA
SESSION 5: A Drug‐Device Combination Product Development Simulation (an Enhanced Learning Experience for In‐Person Attendees Only).
This highly interactive in‐person experience will simulate the process of developing a drug‐device combination product.
In‐person attendees will join industry representatives and FDA staff in exercises simulating the development of a mock complex generic drug‐device combination product. During this experience, in‐person attendees will:
- Actively participate in identifying development challenges and working through solutions.
- Explore human factors considerations during device development or selection.
- Take advantage of the opportunity to handle and manipulate approved and cleared devices with different design
features. - Decide when and how to use available pre‐ANDA submission processes and how to respond to FDA feedback
efficiently and effectively. - Consider how the preparation for this mock ANDA submission and review process can inform future ANDA
submissions for complex generic drug‐device combination products.
Introduction to Session 5
Betsy Ballard, MD, Medical Officer on Team D, Device Evaluation Team, DTP‐I, ORS, OGD, FDA
Moderators:
- Kimberly Witzmann, MD, Deputy Director, OSCE, OGD, FDA
- Ifeanyi U. Uwemedimo, PhD, Senior Scientific Reviewer, OCP, OCPP, OC, CDRH, FDA
- Kristina Lauritsen, PhD, Combination Product Policy Advisor, PJO, OGD, FDA
- Tzach Bachar, MS, Director, Regulatory Affairs, Padagis Israel Pharmaceuticals Ltd
- Brandon Wood, BS, Director, Regulatory Affairs, Gx Steriles, Teva Pharmaceuticals USA Inc.
- Mitul Patel, BPharm, MPharm, Senior Manager – Regulatory and Business Continuity, Sun Pharmaceutical Industries Limited
- Satyashodhan Patil, BE, PGDIBO, Deputy General Manager (R&D), Device Development, Sun Pharmaceutical Industries Limited
- Katharine B. Feibus, MD, Team Leader, Device Evaluation Team (Team D), DTP‐I, ORS, OGD, FDA
- Jason Flint, MBA, PMP, Associate Director of Human Factors, DMEPA‐I, OMEPRM, OSE, FDA
- Claire McDiarmid, MS, Senior Director, Viatris Global Development, Viatris, Inc.
- Ripen Misri, PhD, Director, Co‐Development, Global R&D, Apotex Inc.
- Yili Li, PhD, Senior Pharmaceutical Quality Assessor, OLDP, OPQ, FDA
- Meenal Chavan, PhD, Senior Pharmaceutical Quality Assessor, DIMRP‐III, OLDP, OPQ, FDA
- Michelle Lin, MD, Senior Physician, DCR, OSCE, OGD, FDA
- Viral Jogani, MPharm, PhD, General Manager (R&D) – FR&D, Sun Pharmaceutical Industries Limited
- P, Srinivas Naidu, MEng, Senior General Manager (R&D) – Packaging and Medical Devices, Sun Pharmaceutical Industries Limited
For more information: If you have any questions about this workshop please contact info@complexgenerics.org.
