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.
All 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
2023
- Safety Outcomes When “Switching” Between Biosimilars and Reference Products
- Computational Simulations Shed Light on Factors Affecting Nasal Spray Distribution
- Bispecific Antibodies: An Area of Research and Clinical Applications
- Laboratory Study Shows Oral Antacid Drug Performs Differently When Mixed with Various Food Vehicles
- Using Patient-Reported Outcomes to Measure Frailty in Patients with Multiple Myeloma
- The Role of Disclosures: Helping to Understand Oncology Clinical Trial Endpoints
- Pharmacodynamic Biomarkers: Their Role in Biosimilar Product Development
2022
- Assessing the Respiratory Effects of Approved Opioid Products When Co-administered with Commonly Prescribed Drugs
- A Real-World Case Study of Levothyroxine Use Addresses Institutional Concerns About Generic Product Interchangeability
- Learning from Patient Text Messaging to Optimize Opioid Prescribing and Reduce Misuse
2021
- First-of-kind Pediatric ECG Data Warehouse for Use in Pediatric Product Development Programs and Prevention of Sudden Cardiac Death in the Young
- Ensuring the Rigor of Regulatory Science: CDER Conducts Laboratory and Clinical Studies to Investigate Reports of NDMA Production from Ingested Ranitidine Products
2020
- Remdesivir (Veklury) Approval for the Treatment of COVID-19—The Evidence for Safety and Efficacy
- Real-world Evidence from a Narrow Therapeutic Index Product (Levothyroxine) Reflects the Therapeutic Equivalence of Generic Drug Products
- Promoting Innovation in Medical Product Assessment: A Risk-based Framework for Evaluating Computational Models for Regulatory Decision-Making
- Rigorous Detection of Nitrosamine Contaminants in Metformin Products: Balancing Product Safety and Product Accessibility
- Translating In Vitro Antiviral Activity to the In Vivo Setting: A Crucial Step in Fighting COVID-19