EXECUTIVE SUMMARY
Introduced in March 2024, the FDA Modernization Act 3.0 builds upon the 2022 legislation by requiring FDA reviewers to receive training on New Approach Methodologies and mandating agency acceptance of qualified alternative testing methods. This expansion addresses implementation challenges from the original act and ensures consistent regulatory review of NAMs-based submissions.
KEY PROVISIONS
- FDA Staff Training: Mandatory NAMs education for all drug reviewers
- Acceptance Requirements: FDA must accept qualified NAMs data
- Reporting Mandates: Annual reports on NAMs adoption progress
- Stakeholder Engagement: Required industry consultation on implementation
- Timeline Accountability: Specific implementation deadlines with Congressional oversight
IMPLEMENTATION REQUIREMENTS
- Develop comprehensive NAMs training curriculum within 12 months
- Train all CDER and CBER reviewers within 24 months
- Establish clear guidance documents for NAMs submissions
- Create public database of accepted alternative methods
- Report to Congress on implementation progress annually