FDA Guidances, MaPPs : Multi-Regional Clinical Trials, 510(k) Third-Party Review, Drug Safety Oversight Board – Drug and Device Digest

FDA BRIEF: Week of September 12, 2016

SCOPE

• Multi-regional clinical trials (MRCTs) to address increasing globalization of drug development
• General and Strategic principles for planning and design of MRCTs  for global regulatory submissions

PLANNING & DESIGN OF MRCTs

• Value in Drug Development
• Basic Requirements and Key Considerations
• Scientific Consultation Meetings with Regulatory Authorities
• Clinical Trial Design and Protocol-related Issues
• Regional Variability and its Potential Impact on Efficacy and Safety
• Subject Selection
• Dose Selection of Doses
• Endpoint Selection
• Comparator Selection
• Statistical Analysis Plan
• Overall Sample Size and Allocation to Regions
• Efficacy and Safety Information Collecting and Handling
• Handling Concomitant Medications

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SCOPE

• Third Party (TP) Review Program authorized under section 523 of FD&C Act
• Recognition, Rerecognition, Denial, and Withdrawal processes and criteria
• Harmonized with International Medical Device Regulators 114 Forum’s (IMDRF) regulatory assessment program – Medical Device Single Audit 115 Program (MDSAP)

510(k) REVIEW BY TP

• Device Eligibility
• Relevant FDA guidance(s) and information
• FDA Branch Chief Consult
• Administratively complete submission
•  Product Specialist(s) and Technical Expert(s) selection
• Substantive review
• Identifying deficiencies
• Documenting review
• TP Review documentation
• Additional information per FDA request
• Dispute resolution

RECOGNITION & RERECOGNITION OF TP ORGANIZATIONS

• Operational considerations..
• Management of impartiality
• Personnel
• External Technical Experts
• Outsourcing
• Confidential information
• Complaints
• Record keeping

CONTENT & FORMAT FOR RECOGNITION & RERECOGNITION OF TP ORGANIZATIONS

Initial recognition

• Administrative information
• Prevention of conflicts of interest
• Personnel qualifications.
• Certification statements.

Rerecognition

Recognition or rerecognition denial

Recognition Suspension or Withdrawal

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MaPP: Drug Safety Oversight Board

• Drug Safety Oversight Board (DSB) in 2005
• Provide oversight for management of drug safety issues,  internal deliberations,   review disputes regarding Risk Evaluation and Mitigation Strategies (REMS)
• Internal management council providing advice to CDER Director

SCOPE

• Policy
• Responsibilities – Chairperson, Executive Director, Members, Staff
• Procedures – Referrals, Attendance, Decision-Making, Conflict of Interest

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