FDA BRIEF: Week of August 22, 2016

fda guidances

zika.JPG

UNIVERSAL TESTING of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.

ZIKV IDENTIFICATION

  • Transfusion-Transmitted Infection (TTI) under 21 CFR 630.3(1)
  • Relevant Transfusion-Transmitted Infection (RTTI) under 21 CFR 630.3(h)(2).

Determination based on

  • severity of disease
  • risk of transfusion-transmission by blood and blood components
  • availability of appropriate screening measures
  • significant incidence and prevalence affecting the potential donor population

RECOMMENDATIONS

  •  Testing and Pathogen Reduction
  • Donor and Product Management
  • Labeling of Whole Blood and Blood Components Intended for Transfusion

READbenefit-risk.JPG

PRINCIPAL FDA FACTORS for benefit-risk determinations for PMA and De Novo

STATUTORY Standards

  • RASE- Reasonable Assurance of Safety and Effectiveness
  • De Novo devices : May not need to confer as substantial a benefit;  should sufficiently explain  risks-benefits; risks appropriately mitigated by general and/or special controls

SCIENTIFIC EVIDENCE

  • Clinical: Randomized, well-controlled, in target population
  • Non-Clinical: Performance testing for safety/reliability/characterization, human factors and usability engineering, animal, cell-based studies

BENEFIT ASSESSMENT

  • Type, Magnitude, Probability, Duration

RISK ASSESSMENT

  • Severity, type, number, rate,probability, duration,

ADDITIONAL FACTORS:

  • Uncertainty, Disease characterization, Patient-Centric assessments, Patient Preference, Availability of alternative treatments, Risk Mitigation, Poatmarket data. Novel Technology, Unmet Need

WORKSHEETS  and EXAMPLES provided

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pp.JPG

PATIENT PREFERENCE INFORMATION (PPI) can provide a unique and important perspective on benefits-risks of certain medical devices; part of FDA’s Partner with Patients CDRH 2016-2017 Strategic Priority.

  • Definition: Qualitative/Quantitative assessments of relative desirability or acceptability to patients of specified alternatives or choices …
  • Estimates of how much different outcomes valued by patients vs. tradeoffs
  • Only for certain devices :  Direct patient interface, yield significant health and appearance benefits, treat a rare disease, novel technology

GUIDANCE OUTLINES:

  • Voluntary submission for PMA, HDE, De Novo pathways –
  •  Linking to new Benefit-Risk guidance (described above)-  PPI part of totality of evidence from clinical and nonclinical testing
  • Quantitative Methods : Stated preference, Revealed preference
  • Recommended Study Qualities : Patient Centeredness, Generalizability, Heterogeneity, Good Research Practices, Benefit/Harm/Risk/Uncertainty Communication,  Cognitive Bias, Relevance, Robustness of Analysis, Study Conduct, Comprehension by Study Participants:
  • Additional Considerations:   Integrity,  Conditions of Approval
  • FDA Engagement and Submission: Pre-Submission meeting discyussion, Labeling

EXAMPLES are provided

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antibac.JPG

ANTIBACTERIAL DRUG DEVELOPMENT and  development, analysis, and presentation of microbiology data

EARLY DEVELOPMENT/NONCLINICAL

  • Antibacterial Spectrum of Activity
  • Mechanism of Action
  • Intracellular Antimicrobial Concentration Assessment
  • Resistance Studies
  • In Vitro Antimicrobial Susceptibility Test Methods During Drug Development

EARLY CLINICAL DEVELOPMENT

  • Provisional Antibacterial Susceptibility Test Interpretive Criteria
  • Establishing In Vitro Antibacterial Susceptibility Test Interpretive Criteria
  • Quality Control Parameters

OTHER

  • First and Second Lists of Target Bacteria in Labeling
  • Antibacterial Interactions and Fixed Combination Studies
  • Additional Nonclinical Studies of Antibacterial Drugs
  • Animal Models of Infection
  • Microbiology Information Collected in Clinical Trials
  • Electronic Submission of Microbiology Information
  • Postmarketing Microbiology Information

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