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Identifying the Reference Listed Drug for ANDA Submission, Overview of FDA’s Orange Book, and Exclusivities for NDAs and ANDAs
Session Chair(s)
Kendra Stewart, PharmD, RPh
Supervisor, Orange Book Staff, Office of Generic Drug Policy, CDER
FDA, United States
FDA’s Orange Book and other information resources are essential to potential applicants in developing their generic submissions. This session will provide an overview of these resources and the different information that each contains.
Learning Objective : Describe the content of FDA’s Orange Book; Identify and understand drug product, patent, exclusivity, and therapeutic equivalence information in the Orange Book; Explain FDA’s process for making exclusivity determinations. Describe the process to qualify for Paragraph IV and Competitive Generic Therapy 180-day exclusivities as well as events which may result in exclusivity forfeiture. Understand which applicants are blocked by these exclusivities and triggering events.
Speaker(s)
Orange Book Overview
Kendra Stewart, PharmD, RPh
FDA, United States
Supervisor, Orange Book Staff, Office of Generic Drug Policy, CDER
Identifying the Reference Listed Drug for ANDA Submissions
Martha Nguyen, JD
FDA, United States
Director, Division of Policy Development, OGD, CDER
Understanding Exclusivities for ANDAs: 180-Day Exclusivity and Competitive Generic Therapy Exclusivity
Martin Shimer
FDA, United States
Deputy Director, Division of Legal and Regulatory Support
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