FDA BRIEF: Week of July 18, 2016

Voice

 

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

Howard Sklamberg

Lou Valdez

Donald Prater

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.JPG

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

READ


 

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