FDA BRIEF: Week of July 18, 2016

fda guidances

PBRER

QA

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

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Q&A


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CLIACOLLECTION 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

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