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About the Speakers

David Keire, PhD
Director of Testing and Research
Office of Testing and Research
Office of Pharmaceutical Quality
Center for Drug Evaluation and Research (CDER)

Dr. David Keire received a Ph.D. in Analytical Chemistry at the University of California, Riverside in 1990 with a focus on nuclear magnetic resonance (NMR) spectroscopy. Dr. Keire joined the Center for Drug Evaluation and Research’s Office of Testing and Research (OTR) in 2008 and provided expertise in characterizing complex drugs such as heparin. He is now the OTR Office Director and for the past three years he has participated in the Office of Pharmaceutical Quality (OPQ) and the CDER Nitrosamine Task Forces and international nitrosamine working groups.

Jeffry Florian, PhD
Associate Director
Division of Applied Regulatory Science
Office of Clinical Pharmacology, Office of Translational Sciences
Center for Drug Evaluation and Research (CDER)

Dr. Jeffry Florian is the Associate Director in the Division of Applied Regulatory Science (DARS) where his primary responsibilities have included clinical trial design, drug-disease modeling, and biomarker identification for biosimilar development. Jeffry is prominently involved in expanding the clinical study research capabilities within the Division of Applied Regulatory Science (DARS). His work spans topics such as sunscreen absorption, biomarker identification for biosimilar development, opioid safety with concomitant medications, opioid antagonist drug development and use, and urinary excretion of ranitidine metabolites.

About the Presentation

Researchers at the Center for Drug Evaluation and Research (CDER) conducted and published clinical and nonclinical studies in response to concerns whether ranitidine converts to the probable human carcinogen N-nitrosodimethylamine (NDMA) in humans. This research found no evidence of elevated NDMA content in urine or blood when participants consumed ranitidine and showed that ranitidine does not convert to NDMA in vitro studies under physiologic gastric nitrite concentrations.

Learning Objectives

After completion of this activity, the participant will be able to:

• Describe how the FDA investigated and responded to NDMA impurities in ranitidine products.
• Discuss results from a clinical study and in vitro investigations initiated by the FDA that refute concerns that ranitidine is converted to NDMA in humans.
• Explain how the Center for Drug Evaluation Research's capabilities and activities empower the agency to respond rapidly to emergent regulatory and public health questions regarding the products it regulates.

Webcast Recording:

https://collaboration.fda.gov/p9oq7j6y76zz/

Event Materials:

Activity Outline FDA Grand Rounds: October 14, 2021

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