More Spotlight on CDER Science Articles
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
2019
- Assessing effects of drugs in wastewater on aquatic wildlife
- New FDA Study Shines Light on Sunscreen Absorption
- A Novel Mouse Model Offers Insights About Hypersensitivity to an HIV Drug
- New Drug Class Employs Novel Mechanism for Migraine Treatment and Prevention
2018
- CDER Scientists Investigate Critical Cellular Functions That Can Be Targeted to Kill Cancer Cells
- New Class of Drugs Fulfills Promise of RNA-based Medicine
- Advancing the Science of Nanotechnology in Drug Development
- CDER Scientists Use Modern Measurement Tools for Quality Assurance and Comparability of Complex Drugs
2017
- CDER Researchers Explore the Promise and Potential of 3D Printed Pharmaceuticals
- In Pursuit of Tardive Dyskinesia: The Breakthrough Designation and Approval of Valbenazine
- FDA Researchers Explore Fundamental Chemical Reaction that Could Threaten the Quality of Therapeutic Protein Products
- Lab Tests in Rodents Suggest Potential New Biomarker for Acute Pancreatic Injury
- Novel Approach Allows Expansion of Indication for Cystic Fibrosis Drug
- Modernizing the Way Drugs Are Made: A Transition to Continuous Manufacturing
- Tuberculosis Biorepository Aims To Bolster TB Drug Development by Facilitating Research on Biomarkers