Back to: Navigating Controlled Correspondences to Support Generic Drug Development
Presenter
Robert Lionberger, PhD
Director
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
The closing remarks by Robert Lionberger focuses on the value of the event for those involved in generic product development. The presentation notes the significant workload the Office of Generic Drugs (OGD) faces, handling 3,000 to 4,000 controlled correspondences yearly. A key goal of the event is to empower participants to use the controlled correspondence process more effectively, providing clarity on how to ask questions in a way that elicits the required answers initially. By being transparent about the intricacies often perceived as “secret knowledge” within the process and offering examples of effective question formatting, the event aims to create substantial value. Effectively using the controlled correspondence program leads to improved applications, a reduction in review issues, and overall increased efficiency in the generic product development system. Participants are encouraged to share feedback on the event’s value to ensure similar helpful sessions continue, supporting the availability of affordable generic products.