Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Plenary and Drugs Track
Presenter
Ranjani Prabhakara, PhD
Policy Lead
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Ranjani Prabhakara, PhD is Policy Lead in the Office of Policy for Pharmaceutical Quality (OPPQ), Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation & Research at the FDA. Ranjani was a Team Leader in CDER/ Office of Compliance/ Office of Manufacturing Quality. Ranjani earned her PhD in immunology from the University of Maryland Medical School in 2009. She also holds a BS in Microbiology and a BA in Psychology.
Prior to joining CDER in 2013 (in what was previously the Office of Manufacturing and Product Quality), Ranjani was a Researcher and CMC Reviewer at CBER’s Office of Vaccine Research and Regulation, where her research and review work focused on protein vaccines against bacterial infections. Before joining FDA, Ranjani worked at the NIH Vaccine Research Center studying HIV vaccines.
Abstract
Ranjani Prabhakara from FDA’s Office of Pharmaceutical Quality presents an overview of the Advanced Manufacturing Technologies (AMT) designation program, established by the Consolidated Appropriations Act of 2023 (FDORA). The presentation begins by defining pharmaceutical quality as assuring the availability, safety, and efficacy of every dose, and introduces advanced manufacturing as novel technologies or established techniques used innovatively to substantially improve the manufacturing process while maintaining or improving drug quality. Drivers for adopting advanced manufacturing include producing higher quality drugs, preventing shortages, and speeding drug development. The AMT designation program specifically covers manufacturing methods meeting statutory criteria in a particular context of use and requires supporting data, such as batch analysis. A draft guidance outlines the program process, submission requirements, and benefits like early FDA interaction, a designated lead, and prioritized application assessment. Notably, any entity, not just applicants, can submit a designation request. The presentation also contrasts the AMT program with other FDA programs like CDER’s ETP and CBER’s CAT. The Q&A session addresses confidentiality, program scope, and the distinction between designation and application validation.