FDA and the Center for Research on Complex Generics (CRCG) will host 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.
Registration:
Register now. Registration will close May 4 at 5:00 p.m. (ET) for in-person attendance and May 10 at 7:00 p.m. (ET) for virtual attendance.
The cost for in-person attendance is $100 and will cover event-related expenses. This training is free for virtual attendees.
For faculty and students from the University of Maryland, Baltimore; Universities at Shady Grove; and University of Michigan, the training is free for in-person attendance. Please contact us and indicate which workshop you are interested in.
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 Outline:
Introduction to the Training
A speaker from the Office of Generic Drugs will introduce the training and its sessions in the context of facilitating the development of generic complex drug-device combination products. The speaker will review learning objectives, session topics, and training formats.
- Presentations by experts from FDA and CRCG
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.
- Presentations by experts from FDA and the generic drug industry
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.
- Presentations by experts from FDA and the generic drug industry
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?
- Presentations by experts from FDA and the generic drug industry
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.
- Presentations by experts from FDA and the generic drug industry
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.
For more information: If you have any questions about this workshop please contact info@complexgenerics.org.
