Back to: FDA Generic Drugs Forum 2025
Presenter
Thu (Suzanne) Phan, PharmD
Pharmacist, Division of Legal & Regulatory Support (DLRS)
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)
Suzanne Phan is a Pharmacist with the Patent and Exclusivity Team. Prior to joining the FDA, Suzanne worked as a Pharmacy Research Coordinator at Inova Schar Cancer Institute. She earned her PharmD from Virginia Commonwealth University and undergraduate degree in Biology from George Mason University.
Abstract
At the 2025 Generic Drugs Forum, Suzanne Phan, a pharmacist with the FDA’s Patent and Exclusivity Team, delivers a detailed presentation on how minor regulatory errors—particularly those related to Paragraph IV (PIV) certifications—can cause major delays in ANDA approvals. She identifies three common issues: missing or incorrect notice documentation, improper notification of patent litigation status, and failure to address newly listed patents or use codes. Phan outlines the regulatory requirements under 21 CFR 314.95, emphasizing the importance of timely, accurate PIV notice delivery and proof of receipt. She also distinguishes procedures for original ANDAs versus later-listed patents, reiterating that improper timing or documentation can result in policy-only complete response letters. Additionally, she discusses Form 356h requirements and the necessity of submitting accurate civil case numbers when litigation occurs. Phan concludes by urging applicants to stay vigilant with patent certifications and communication to avoid preventable delays in the FDA review process.