Back to: FDA Generic Drugs Forum 2025
Presenter
Truong Quach, PharmD
Team Lead
Division of Orange Book and Regulatory Assessment (DOBPRA)
Office of Generic Drug Policy (OGDP)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Truong Quach is a team lead pharmacist working in the Office of Generic Drugs Policy, Division of Orange Book Publication and Regulatory Assessment (DOBPRA) since 2018 and has been with the FDA since 2014. As an Orange Book TL pharmacist, he helps the Orange Book publication by identifying drug products approved on the basis of safety and effectiveness by the FDA and related patent and exclusivity information. As a subject matter expert in DOBPRA, Truong is also responsible for reviewing approved labeling and the content of clinical data in new drug original and efficacy supplement approvals to make Hatch-Waxman exclusivity determinations.
Abstract
At the 2025 Generic Drugs Forum, Truong Quach presents a detailed overview of the FDA’s Orange Book, focusing on drug marketing status and the requirements under Section 506I of the FD&C Act. He traces the Orange Book’s history, outlines its structure and update frequency, and explains how marketing status changes are managed and reported. Quach highlights obligations for NDA and ANDA holders regarding notifications for drug withdrawal, non-marketing, or relaunch, emphasizing the importance of accurate, timely submissions through the electronic gateway. He also presents three real-world case studies illustrating common challenges and best practices in handling marketing status updates, and concludes with quiz questions to reinforce key regulatory concepts.