Back to: FDA Generic Drugs Forum 2025
Presenter
Arun Agrawal, PhD
Pharmacologist, 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)
Dr. Arun Agrawal is currently a Pharmacologist (bioequivalence assessor) in DBI, OB, OGD, and is responsible for the assessment of bioequivalence parts of various dosage forms of generic drugs (e.g., ANDAs, Controlled Correspondences, etc.). Prior to joining OGD in 2014, he worked for 5 years as a Pharmacologist in the Office of Clinical Pharmacology, FDA, assessing new drug applications (NDAs). Prior to joining the FDA in 2009, he worked in the pharmaceutical industry for over 11 years, and before that in academic institutions doing teaching and research for over 14 years. Dr. Agrawal received his Ph.D. in Biochemistry at the Central Drug Research Institute, Lucknow, India.
Abstract
Arun Agrawal discusses post-Complete Response Letter (CRL) scientific meetings at the Generic Drugs Forum 2025, focusing on the GDUFA III commitment letter and how these meetings support generic drug development. He explains when FDA grants meeting requests, particularly for complex generic products that require scientific advice on addressing deficiencies related to establishing bioequivalence. Agrawal shares insights from the 41 post-CRL meeting requests received, including their formats, common reasons for meeting denial, and examples of case studies. He emphasizes the importance of submitting a complete meeting package, clearly defining complex product criteria, and specifying the desired meeting format. He also highlights the key expectations for applicants to avoid denial, such as providing sufficient data and focusing on scientific approaches rather than addressing review deficiencies directly. The session concludes with take-home messages on how to effectively navigate post-CRL scientific meetings to improve approval processes.