这 食品和药物管理局 (FDA) has scheduled a public meeting titled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act (BPCA) and Paediatric Research Equity Act (PREA)” on May 15, 2025. This event will provide a platform for stakeholders to discuss the impact of paediatric legislation on drug and biologic development, shaping future advancements in paediatric healthcare.
Meeting Objectives:
The FDA seeks input from diverse stakeholders—including patient groups, caregivers, industry representatives, and academia—to:
- Evaluate Public Health Impact: Examine how BPCA and PREA have influenced paediatric treatment options and addressed unmet medical needs.
- Balance Incentives and Requirements: Explore how incentives under BPCA and study mandates under PREA affect drug development plans.
- Identify Barriers: Discuss challenges like clinical trial infrastructure, enrolment diversity, and hurdles preventing study completion.
- Leverage Scientific Advances: Highlight innovative approaches like paediatric extrapolation, adaptive trial designs, biomarkers as surrogates, and real-world data to improve evidence generation for paediatric populations.
- Enhance Global Alignment: Address the importance of international collaboration in paediatric drug development.
Event Details:
- Date: May 15, 2025
- Time: 9:00 a.m. – 4:30 p.m. Eastern Time
- Location:
- Virtually
- Onsite: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the White Oak Great Room, Silver Spring, MD 20993-0002
How to Participate:
- Stakeholders are encouraged to attend the meeting and share their experiences related to BPCA and PREA.
- Electronic or written comments on the meeting must be submitted by June 13, 2025.
Impact on Paediatric Drug Development:
This public meeting will influence strategies for paediatric drug and biologic development, emphasizing areas with high unmet medical needs. The FDA’s focus on leveraging advanced scientific methodologies such as real-world data, adaptive trials, and paediatric extrapolation offers an opportunity for stakeholders to align their development plans with evolving regulatory expectations.
This meeting reflects the FDA’s commitment to advancing paediatric healthcare through collaboration, innovation, and robust regulatory frameworks.
