FDA Grand Rounds

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The FDA Grand Rounds is an educational presentation that is webcast monthly to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute educational presentation is followed by questions from the audience. You can also view the presentation under Past Grand Rounds following the live webcast. #FDAGrandRounds.

Laboratory and Clinical Studies to Investigate Whether Ranitidine Converts to a Probable Carcinogen in Humans

Thursday, October 14, 2021
12:00 p.m. - 1:00 p.m. EST
Webcast

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.

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Past Grand Rounds

2021

• Immune System Responses to Therapeutic Proteins: Getting up close and personal
• SARS-CoV-2: Host-pathogen interaction, vaccines & variants of concern
• FDA's work with African Swine Fever from a policy and regulatory perspective 
• Project Orbis: Global Collaborative Oncology Review Program
• Electrical Safety in CTP Regulated Products
• Studies of SARS-CoV-2 NSP1 and Envelope Protein
• Research and Development of Radioanalytical Capabilities for Detection of Radionuclides in Food
• FDA Grand Rounds: The CORE Network (or How I Learned to Love Lettuce…)

2020

• Assessment of Safety and Efficacy of Fecal Microbiota for Transplantation Products
• Facial Coverings During the COVID-19 Pandemic: How well do they flatten the curve?
• Bioequivalence of Complex Topical Generics: In Vitro and In Vivo
• Advancing the Science of Real-World Data to Address the COVID-19 Pandemic
• Nanotechnology: Over a Decade of Progress and Innovation at FDA
• A Pandemic and a Call to Action for One Health: The FDA One Health Initiative
• Artificial Intelligence for Regulatory Science Research
• Analysis of Per and Polyfluoroalkyl Substances (PFAS) in foods- Analytical method development, challenges and successes
• Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology
• Detection of Transmissible Spongiform Encephalopathy Agents in Biological Products Using Protein Aggregation Assays
• Quality Control: Stopping infections before they happen through safer endoscope reprocessing

2019

• Vet-LIRN – How FDA’s Network of Veterinary Diagnostic Laboratories advance animal food safety and public health by conducting outbreak investigations and monitoring resistance in animal pathogens
• Technical and Logistical Considerations for Examining FDA-Regulated Products at International Mail Facilities using Handheld and Field-Portable Analytical Devices

• Why FDA authorized the marketing of the IQOS heated tobacco product as “appropriate for the protection of the public health”

• Overview of FDA's Perinatal Health Center of Excellence: Development and Validation of Predictive Systems

• Cyclospora Cayetanensis: The Crossroads Between Scientific Advances and Knowledge Gaps 

• Gaining Insight into the Patient’s Experience by Harnessing the Power of Social Listening and FDA Archival Data 

• Uncertainty is the only certainty there is: Potential approaches for making public health decisions

• The VICTRE trial: an in-silico replica of a clinical trial for evaluating digital breast tomosynthesis as a replacement for full-field digital mammography

2018

• Jerky Pet Treats and illness in dogs:  a collaborative approach to investigating a mysterious outbreak
• Decomposition of Seafood Products by Mass Spectrometry with Sensory-Driven Predictive Modeling
• The Science to Inform a Tobacco Product Standard for the Level of Nicotine in Combusted Cigarettes
• Bisphenol A: Toxicology and Pharmacokenetic Data to Inform Ongoing Safety Assessments
• How Simulation Can Transform Regulatory Pathways
• FDA's Predictive Toxicology Roadmap: Implications and Opportunities for Stakeholders
• Are Stem Cells Ready for Prime Time? A Look at FDA Research Advances in Regenerative Medicine
• Ethnicity- and Gender-Related Differences in Alzheimer's Disease

2017

• Assessing the Safety and Effectiveness of New and Emerging Therapeutic Ultrasound Technologies
• Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs
• Genome Trakr: How a Large Network of Sequencing Laboratories is Transforming Food Safety and Public Health
• Serious and Actionable Risks, Plus Disclosure: investigating an Alternative Approach for Presenting Risk Information in Prescription Drug TV Ads
• Vaccine adjuvants: New ways to evaluate their safety and effectiveness
• Developing Regulatory Methods for Characterizing Nanomaterials in FDA-Regulated Products

2016

• The Host Response to Whooping Cough Infection and Vaccination [Archived]
• Antibiotic resistance surveillance in the age of genomics: New answers to old questions [Archived]
• FDA Research into 3D Printing of its Regulated Products [Archived]
• Rapid Screening of Dietary Supplements for Undeclared Ingredients [Archived]
• Metabolomics and Proteomics Biomarkers: Discovery and Validation in Toxicity Studies [Archived]

Resources For You

• FDA's Predictive Toxicology Roadmap
• Don't Miss the CDC Public Health Grand Rounds