Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Biologics Track
Presenter
Cara Pardon, MS
Regulatory Project Manager (RPM)
Division of Review Management and Regulatory Review 1 (DRMRR1)
Office Review Management and Regulatory Review (ORMRR)
Office of Therapeutic Products (OTP)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)
Cara Pardon, M.S. is a Regulatory Project Manager (RPM) in the Office of Review Management and Regulatory Review, Office of Therapeutic Products, Center for Biologics Evaluation and Research. Cara is a regulatory expert and project manager, with a passion for protecting public health and safety. Since joining FDA as an RPM in November of 2020, Cara has provided review management throughout the product life cycle, from pre-submission meetings to post-marketing submissions. As an RPM, Cara also acts as the liaison between FDA and industry, managing all communications and meetings. Prior to her work at FDA, Cara served as a Biologist at the National Cancer Institute (NCI), National Institutes of Health (NIH). Cara received her Bachelor of Science from The University of Wisconsin-La Crosse and her Master of Science from Cornell University.
Abstract
This presentation by Cara Pardon from FDA’s CBER Office of Therapeutic Products (OTP) provides an overview of the various regulatory submissions reviewed by the office. It covers submissions under the Prescription Drug User Fee Act (PDUFA) for biologics and drugs, and the Medical Device User Fee and Modernization Act (MDUFA) for certain medical devices. Key submission types discussed span the product lifecycle, including early interactions like Interact meetings and Pre-IND meetings for biologics, and Q submissions for devices, aimed at obtaining early feedback on development plans. The presentation details submissions required for clinical studies, such as Investigational New Drug (IND) applications and Investigational Device Exemptions (IDE). It outlines marketing applications, including Biologics License Applications (BLAs) under PDUFA, and various premarket submissions for devices under MDUFA, such as 510(k)s, De Novo requests, HDEs, PMAs, and device BLAs. Post-marketing submissions for both product types are also covered. The presentation emphasizes the interactive review processes, associated timelines, and best practices for submissions and communication with OTP. Understanding these different submission types and processes is crucial for navigating the product lifecycle from preclinical development through post-market activities.