Spotlight on CDER Science
Spotlight on CDER Science highlights the critical scientific research and advancements by the Center for Drug Evaluation and Research (CDER), showcasing the latest developments in drug evaluation and regulatory science, while offering insights into how science drives drug safety and effectiveness.
Latest CDER Science Spotlights
Determining Recommended Acceptable Intake Limits for N-nitrosamine Impurities in Pharmaceuticals: Development and Application of the Carcinogenic Potency Categorization Approach
FDA and international regulators developed a methodology, the Carcinogenic Potency Categorization Approach, that uses the chemical structure of a nitrosamine impurity to recommend AI limits by assignment to 1 of 5 predicted potency categories reflecting carcinogenic risk.
Healthcare Providers’ Use of a Concise Summary to Prescribe for Lactating Patients
CDER collaborated with the Center for Biologics Evaluation and Research and outside researchers to conduct a study to explore if adding a concise summary of risk information would more succinctly communicate drug safety information to busy healthcare providers.
Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide Impurity Formation and its Inhibition in Bumetanide Tablets
CDER research provides manufacturers with potential approaches to drug formulation to mitigate nitrosamine formation.
Prescriber Perceptions of Boxed Warnings: A Qualitative study
An important part of CDER’s work is communicating the most up-to-date safety information for medicines to help ensure that health care providers (HCPs) and their patients can make the most informed treatment decisions.
Using Machine Learning to Identify a Suitable Patient Population for Anakinra for the Treatment of COVID-19
CDER review team discusses how machine learning was used to identify the most suitable COVID-19 patients for treatment with Anakinra under an Emergency Use Authorization (EUA), improving the precision of patient selection and potentially enhancing treatment outcomes.
Sociodemographic Characteristics of Adverse Event Reporting
Researchers in CDER’s Office of Surveillance and Epidemiology and other experts examine how sociodemographic factors like age, sex, and race influence adverse drug events reporting and the potential impacts on understanding drug safety across different populations.
CDER Science Spotlights
2024
- Healthcare Providers’ Use of a Concise Summary to Prescribe for Lactating Patients
- Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide Impurity Formation and its Inhibition in Bumetanide Tablets
- Prescriber Perceptions of Boxed Warnings: A Qualitative study
- Using Machine Learning to Identify a Suitable Patient Population for Anakinra for the Treatment of COVID-19 Under the Emergency Use Authorization
- Disease Awareness and Prescription Drug Communications on Television: Evidence for Conflation and Misleading Product Impressions
- Sociodemographic Characteristics of Adverse Event Reporting
2017-2023
Review past Spotlight on CDER Science articles from 2017-2023.