FDA BRIEF: Week of September 12, 2016

fda guidances

Image result for ICH

e17.JPG

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

READ


third party.JPG

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

READ


 

Image result for FDA manual of policy and procedures

mapp

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

READ


 

 

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