A forum to improve safety assessments for nitrosamine impurities in medications
Nitrosamines Forum to Advance Critical Translational Science (NA FACTS)
This study is bringing together experts to talk about safety concerns related to harmful substances in medications, so they can come up with better ways to keep our medicines safe and make information about these substances easier to find.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Health and Environmental Sciences Institute NIH-funded |
| Lab location | 1 site (Washington, United States) |
| Project ID | NIH-11043146 on NIH RePORTER |
What this research studies
This research aims to establish a forum that brings together various stakeholders to address the safety risks associated with nitrosamine impurities found in drugs. The initiative will involve forming advisory teams that will prioritize research needs and develop recommendations for assessing these impurities. Additionally, the forum will explore the creation of a public database to enhance transparency and understanding of nitrosamine classifications. By focusing on both in vivo and in vitro research, the project seeks to ensure that essential medications remain safe and accessible to the public.
Who could benefit from this research
Good fit: Patients who are prescribed medications that may be affected by nitrosamine impurities would be ideal candidates to benefit from this research.
Not a fit: Patients who are not on any medications or those whose treatments are not impacted by nitrosamine impurities may not receive any benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to improved safety standards for medications, reducing the risk of nitrosamine-related health issues for patients.
How similar studies have performed: While the approach of forming multi-stakeholder forums for safety assessments is not widely tested, similar initiatives in other areas of drug safety have shown promise in improving public health outcomes.
Where this research is happening
Washington, United States
- Health and Environmental Sciences Institute — Washington, United States (Active)
Researchers
- Principal investigator: Jiang, Connie L — Health and Environmental Sciences Institute
- Study coordinator: Jiang, Connie L
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.