Improving drug approval processes and biosimilar regulations
Cooperative Agreement to Support Regulatory Research Related to the 2022 Prescription Drug User Fee Act and Biosimilar User Fee Act (U19)
This study is working with the FDA to make it easier and faster for new medicines to get approved, which could help patients get safe and effective treatments more quickly.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Duke University NIH-funded |
| Lab location | 1 site (Durham, United States) |
| Project ID | NIH-10840930 on NIH RePORTER |
What this research studies
This research focuses on enhancing regulatory science related to drug approvals and biosimilars by collaborating with the FDA. The project involves organizing public conferences, expert workshops, and other convening activities to address key challenges in drug regulation. By bringing together stakeholders from the pharmaceutical industry, government, and academia, the research aims to identify priority topics and develop strategies to expedite drug development and approval processes. Patients may benefit indirectly through improved access to safe and effective medications resulting from these regulatory advancements.
Who could benefit from this research
Good fit: Patients who are seeking new treatment options or therapies that may be expedited through improved regulatory processes would be ideal candidates to benefit from this research.
Not a fit: Patients with conditions that are not addressed by new drug approvals or biosimilars may not receive direct benefits from this research.
Why it matters
Potential benefit: If successful, this research could lead to faster and more efficient drug approvals, ultimately improving patient access to new therapies.
How similar studies have performed: Previous collaborative efforts in regulatory science have shown promise in improving drug approval timelines and processes, indicating that this approach has potential for success.
Where this research is happening
Durham, United States
- Duke University — Durham, United States (Active)
Researchers
- Principal investigator: Hamilton Lopez, Marianne — Duke University
- Study coordinator: Hamilton Lopez, Marianne
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.