Spotlight on CDER Science
Sociodemographic Characteristics of Adverse Event Reporting
Postmarketing surveillance is an important way to identify drug-related adverse reactions (side effects) that may not be observable in the clinical trial setting because it is a relatively controlled environment. Compared to participants in clinical trials, real-world patient populations are generally more demographically diverse and are more likely to have additional medical issues and take other medications.
Previous Spotlight on CDER Science Articles
2024
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