Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Biologics Track
Presenter
Craig Zinderman, MD, MPH
Associate Director for Medical Policy
Office of Biostatistics and Pharmacovigilance (OBPV)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)
Craig Zinderman, MD, MPH is the Associate Director for Medical Policy in the Office of Biostatistics and Pharmacovigilance (OBPV) at FDA’s Center for Biologics Evaluation and Research. He serves on inter- and intra-Center working groups developing FDA regulations and guidance on post-market safety and adverse event reporting for regulated industry. Dr. Zinderman also provides expertise and advice to Office and Division Leadership on medical product safety surveillance and the management of product safety issues.
Dr. Zinderman has served as a Medical Officer in OBPV since 2004, including serving as Associate Director of the Division of Epidemiology from 2012 to 2020. He has a Bachelor of Science in Biology from the University of Maryland, a Medical Doctorate from the University of Maryland School of Medicine, and a Master in Public Health from the Uniformed Services University of Health Sciences. He is Board certified in General Public Health and Preventive Medicine.
Abstract
This presentation focuses on the revised ICH E2D guideline, which provides updated guidance to marketing authorization holders (MAHs) on the management and reporting of post approval safety information. The guideline establishes harmonized procedures, foundational definitions, and concepts for handling individual case safety reports (ICSRs). A primary driver for the revision of the original 2003 guideline is the emergence and increased frequency of use of new data sources for post-market safety information, such as digital platforms, patient support programs, and market research programs, which present new challenges and burdens for MAHs and regulators. The updated guideline expands the scope to cover all ICSRs and introduces or clarifies definitions for key terms including ICSR (detailing minimum reporting criteria), expedited report, primary source, organized data collection system (ODCS), digital platforms, patient support programs, and market research programs. It distinguishes between spontaneous reports, which are unsolicited communications, and solicited reports, which are derived from organized data collection systems like patient support programs or studies. The revised guideline offers enhanced guidance on how to manage and report cases specifically from sources such as literature, digital platforms (making a distinction based on MAH responsibility), patient support programs, and market research programs. It also addresses the handling of cases identified from regulatory authority sources and clarifies reporting obligations for other observations that are not adverse events, such as lack of effect, medication error, and use in pregnancy, while noting that local and regional requirements must be consulted as variations exist among different regions. The draft guideline was open for public comment, with a final version anticipated in May 2025.