Back to: FDA Generic Drugs Forum 2025
Presenter
Jayani Perera, PhD
Senior Chemist
Division of Product Quality Assessment XIX (DPQAXIX)
Office of Product Quality Assessment III (OPQAIII)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Jayani Perera is a senior chemist in the Office of Product Quality Assessment III (OPQAIII) in the Office of Pharmaceutical Quality (OPQ) in the FDA’s Center for Drug Evaluation and Research. She has assisted in the design, optimization, and management of the GDUFA Completeness Assessment process and the Timely Consult and Early Information Request (TCIR) Process for Drug Master Files. Jayani has also served in the GDUFA III DMF implementation working group and assisted in drafting the Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA draft guidance. Jayani holds a Ph.D. degree in Inorganic/Organometallic Chemistry from Wayne State University in Detroit, Michigan.
Abstract
At the 2025 Generic Drugs Forum, Jayani Perera, a senior chemist at the FDA’s Office of Pharmaceutical Quality, presents on the impact of GDUFA III enhancements to Drug Master File (DMF) assessments. She highlights two key improvements: solicited off-cycle amendment reviews and the prior assessment process. These enhancements allow DMFs to be evaluated outside the traditional ANDA cycle, aiming to increase first-cycle approvals and reduce overall review times. Perera explains the criteria for prioritization, emphasizes the importance of timely email notifications to the DMF OGD mailbox, and stresses strong communication between DMF holders, applicants, and the FDA. She encourages industry stakeholders to utilize these processes, noting they are underused despite offering significant benefits.