FDA Views: TransAtlantic Cooperation, PDUFA VI
FDA BRIEF: Week of July 18, 2016
Addressing Global Challenges through Transatlantic Cooperation
By:
Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy
Mary Lou Valdez, Associate Commissioner for International Programs
Donald Prater, Director of FDA’s Europe Office
MEETING: FDA – EU regulatory counterparts and stakeholders meeting
DISCUSSION: Several topics
- Globalization of suppliers and distributors;
- Keeping pace with risk-based allocation of inspection resources
- Complexity of the global supply chain and the need to collaborate on enforcement
- Progress being made on the Mutual Reliance Initiative
- Pharmaceutical GMP inspection
- Interaction among FDA’s Europe, China, and India offices and regulatory counterparts in the EU and Governments of China and India
Transatlantic cooperation is vitally important to address the challenges and opportunities of a globalized marketplace. READ
PDUFA VI GOAL LETTER
- Represents FDA’s discussions with the regulated industry and public stakeholders
- Formal tracked performance goals for timely access to safe, effective, and innovative drug products for patients
ENSURING EFFECTIVENESS OF REVIEW PROGRAM
- FDA Review Performance Goals
- Enhanced Review Transparency And Communication
- First Cycle Review Management
- Review Of Proprietary Names
- Major Dispute Resolution
- Clinical Holds
- Special Protocol Question Assessment And Agreement
- Meeting Management Goals
- Regulatory Science And Expediting Drug Development
- Regulatory Decision Tools
- Modernization of Drug Safety System
ENHANCING MANAGEMENT OF USER FEE RESOURCES
- Resource Capacity Planning , Time Reporting, Financial Transparency And Efficiency
IMPROVING FDA HIRING AND RETENTION OF REVIEW STAFF
- Hiring System Infrastructure, Hiring Staff Capacity And Capability, Goals, Comprehensive Assessment Of Hiring And Retention
INFORMATION TECHNOLOGY GOALS
- Predictability And Consistency Of Electronic Submission Processes, Electronic Submission And Data Standards Activities