Back to: FDA Generic Drugs Forum 2025
Presenter
Fang Lu, PhD
Team Leader
Division of Bioequivalence I (DBI)
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Fang Lu has a Ph.D. in Toxicology from the University of Nebraska Medical Center. He joined the U. S. Food and Drug Administration in 2009 and is Team Leader of the Division of Bioequivalence I (DBI), Office of Bioequivalence (OB) in the Office of Generic Drugs (OGD). Dr. Lu has solid knowledge of the fields of pharmacology, toxicology, chemistry, and statistics with 16 years of experience in reviewing in vivo and in vitro bioequivalence study data. He is interested in the regulatory scientific research landscape and actively takes on leadership roles for projects and initiatives, including, but not limited to: Assessment of Global Submission Quality and Data Integrity on Bioequivalence Study in Generic Drug Applications, Comprehensive Assessment on Alcohol-Induced Dose Dumping in Generic Drug Products, PK Abuse Deterrence Studies, Impacts of Bio-batch Adequacy on Bioequivalence Evaluations, and Evaluating the Safety of Excipients Used in Generic Drug Formulations with Pediatric Indications.
Abstract
At the 2025 Generic Drugs Forum, Fang Lu, team leader in the FDA’s Division of Bioequivalence I, discusses common bioequivalence (BE) deficiencies identified in Information Requests (IRs) and offers strategies to improve the review process. He explains the purpose and timing of IRs and Late-Cycle IRs (LCIRs), noting that 18% of ANDAs reviewed in FY 2023 received such requests. Most deficiencies stem from issues in in vivo studies, such as inconsistent SAS datasets or missing formulation details. Lu provides real case examples and practical tips—like verifying data consistency, checking expiration dates, and submitting complete, timely responses—to help applicants avoid delays and reduce review cycles. He emphasizes that high-quality applications and applicant responsiveness are critical for achieving BE adequacy and faster approvals, reinforcing the importance of collaboration and clear communication between FDA and ANDA applicants.