FDA BRIEF: Week of July 18, 2016
FORMAT, CONTENT, CONSIDERATIONS for Periodic Benefit-Risk Evaluation Report (PBRER)
- Analysis of new or emerging information on the risks and benefits – appraisal of product’s overall benefit-risk profile
- Relevant new safety information since international birth date (IBD)
GENERAL PRINCIPLES
- Single PBRER for an Active Substance
- PBRERs for Fixed-Dose Combination Product
- Products Manufactured and/or Marketed by More Than One Company
- Reference Information
- Level of Detail
- Efficacy/Effectiveness
- Benefit-Risk Evaluation
- Periodicity and PBRER Data Lock Point
- IBD and Data Lock Point
- Managing Different Submission Frequencies
- Time Interval Between Data Lock Point and Submission
- Format and Presentation
GUIDANCE ON CONTENTS
- Introduction
- Worldwide Marketing Approval Status
- Actions Taken in the Reporting Interval for Safety Reasons
- Changes to Reference Safety Information
- Estimated Exposure and Use Patterns
- Data in Summary Tabulations
- Summaries of Significant Safety Findings From Clinical Trials During the Reporting Interval
- Findings From Non-Interventional Studies
- Information From Other Clinical Trials and Sources
- Nonclinical Data
- Literature
- Other Periodic Reports
- Lack of Efficacy in Controlled Clinical Trials
- Late-Breaking Information
- Overview of Signals: New, Ongoing, or Closed
- Signal and Risk Evaluation
- Benefit Evaluation
- Integrated Benefit-Risk Analysis for Approved Indications
COLLECTION OF INFORMATION for CLINICAL LABORATORY IMPROVEMENT AMENDMENT (CLIA) per FDA Guidance on CLIA waiver for in vitro diagnostics
- Description of features that make it ‘simple’
- Hazard analysis
- Poential sources of error
- Design and results of flex studies
- Fail-safe and Failure Alert mechanisms
- Validation studies
- Clinical tests for test accuracy by intended operators
COST FOR WAIVER : $350,000
- Clinical study costs: Site selection, qualification, protocol review, execution