The FDA/DIA Complex Generic Drug-Device Combination Products Workshop 2018 October 8, 2018

Public | In Person

• Date: October 9, 2018

Date:  October 9-10, 2018

Location:  Sheraton Silver Spring Hotel, 8777 Georgia Ave, Silver Spring, Md 20910 

Meeting Materials:

• FULL AGENDA
• SPEAKER LIST
• REGISTRATION

Background:

The Generic Drug User Fee Amendments of 2012 (GDUFA I) established a research program that was subsequently reauthorized under the FDA Reauthorization Act of 2017 (GDUFA II).  Research initiatives from these programs have identified many challenges related to complex drug-device combination products that will benefit from expanded collaboration with stakeholders.  The FDA/DIA Complex Generic Drug-Device Combination Products Workshop 2018 will be designed by a program committee including members from the Office of Generic Drugs (FDA/CDER), relevant other parts of FDA, the DIA’s steering committee members drawn from the Drug and Device Community of Interest, and other DIA members and industry stakeholders. The workshop will discuss relevant challenges, and relevant research initiatives aimed to address such challenges, associated with the development and review of complex generic drug-device combination products submitted under an Abbreviated New Drug Application (ANDA).  

 

This meeting is intended to be an open forum for the current discussion of topics of mutual scientific and practical interest to researchers, product development scientists and policy analysts who develop and/or have an interest in the development of generic drug-device combination products.  A primary goal for this meeting is to establish an on-going dialogue between industry, academia and regulators, to better address the scientific and regulatory challenges associated with the development of a therapeutically equivalent, generic drug-device combination product.

Goals and Objectives

• Discuss relevant regulatory and policy considerations for drug-device combination products
• Identify scientific considerations for establishing bioequivalence for different complex drug-device combination delivery methods
• Identify specific product quality challenges in developing different approaches to drug-device combination product manufacturing to meet sameness in product performance and cGMP requirements
• Discuss ideas for improving communication and collaboration between industry, academia and the agency in developing novel methods and standards for assessing the sameness of complex generic drug-device combination products.

Who should attend?

The workshop will appeal to researchers and product development scientists who are involved in the development of generic drug-device combination products. Interested persons may also include biopharmaceutical consultants, clinicians, regulatory and medical scientists, and other stakeholders interested in the regulatory and scientific landscape associated with generic drug-device combination products.

Contacts:

• Kris Andre- kris.andre@fda.hhs.gov