FDA BRIEF: Week on May 9, 2016

fda guidances

Hepatitis

  • Clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C (CHC)
  • Each marketing application must contain at least one active-controlled comparative trial

General Drug Development Considerations:

  • Nonclinical Virology Development Considerations (Mechanism of action, Antiviral activity in cell culture, Cytotoxicity and mitochondrial toxicity, Antiviral activity in animal models, Combination antiviral activity, Resistance and cross-resistance
  • General Considerations for Phase 1 and Phase 2 Development (Phase 1a/first-in-human trials, Phase 1b (proof-of-concept), Phase 2 trials with combination DAA regimens
  • Drug Development Population
  • Efficacy Considerations
  • Safety Considerations

Phase 3 Efficacy Trial Considerations:

  • Trial Design (Treatment-naïve, non-DAA treatment-experienced,DAA treatment-experienced)
  • Trial Population
  • Entry Criteria (Assessment of cirrhosis, HCV genotype considerations, DAA treatment experience)
  • Randomization, Stratification, and Blinding
  • Specific Populations (HIV-1/HCV co-infected, decompensated cirrhosis and pre- or post-transplants, pediatric, advanced chronic kidney disease)
  • Dose Selection
  • Efficacy Endpoints
  • Trial Procedures and Timing of Assessments
  • Statistical Considerations (Analysis populations, Efficacy analyses, Noninferiority margin, Handling of missing data, Interim analyses and data monitoring committees, Statistical analysis plan)
  • Accelerated Approval (Subpart H) Considerations

Other Considerations: Nonclinical Safety, PK/PD, Clinical Virology, Expanded Access considerations

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3D.JPG

  • Leapfrog guidance on 3-dimensional (3D) printing to share initial thoughts on emerging technologies
  • Additive manufacturing (AM) builds an object by iteratively building 2-dimensional (2D) layers and joining each to the layer below, allowing device manufacturers to rapidly alter designs without the need for retooling and to create complex devices built as a single piece
  • Guidance outlines considerations for testing and characterization for devices that include at least one AM fabrication step.

Design and Manufacturing Considerations

  • Software Workflow
  • Material controls
  • Post processing
  • Process validation and Acceptance Activities
  • Quality Data

Device Testing Considerations

  • Device Description
  • Mechanical Testing Dimensional Measurements
  • Material Characterization
  • Cleaning and Sterilization
  • Biocompatibility
  • Labeling considerations

DEADLINE for comments: Aug 8, 2016

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3D webFDA has launched  3D Printing Web Content


Idisease

  • Infectious Disease Next Generation Sequencing Based Diagnostic Devices – Infectious Disease NGS Dx devices employimg employing targeted or agnostic sequencing approaches
  • Use: Diagnostic aid for microbial infection and in selecting appropriate therapies
  • NGS technology: Rapid, actionable detection of clinically important pathogenic organisms in human specimens e.g., urine, blood, cerebrospinal fluid, stool, sputum
  •  Systems Approach:  Use a “one system” approach for evaluation – from sample collection through the output of clinically actionable data using methods from the  systems science discipline
  • FDA-ARGOS database: Validated regulatory-grade microbial genomic sequence entries
  • Guidance summarizes
    • BENEFIT-RISK ASSESSMENT
    • DEVICE DESCRIPTION
    • DEVICE VALIDATION
    • DEVICE MODIFICATION
    • COMPARATOR DATABASE QUAITY CRITERIA

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SPA

  • Special Protocol Assessment (SPA) provides for protocol evaluation trials prior to initiation
  • Process for sponsors and FDA to reach agreement on key design elements of clinical/animal studies
  • Sponsors: Submit specific questions about protocol design, scientific, regulatory requirements
  • FDA : Issues SPA Letter including assessment of protocol, agreement or nonagreement, abnd responses to questions
  • SPA agreement : FDA Concurrence with adequacy and acceptability of specific critical protocol design elements that meet regulatory 33 requirements for approval
  • However, existence of SPA agreement does not guarantee FDA filing and approval of NDA
  • Guidance summarizes
    • ELIGIBLE PROTOCOLS AND GENERAL INFORMATION
    • PROCEDURES FOR SUBMISSION OF A REQUEST
    • CONTENT OF A REQUEST AND SUBMISSION MATERIALS
    • FDA ASSESSMENT PROCESS
    • SPONSOR OPTIONS AFTER RECEIPT OF NONAGREEMENT SPA LETTER
    • DOCUMENTATION
    • CHANGES IN OR RESCISSION OF SPECIAL PROTOCOL ASSESSMENT AGREEMENTS
    • DISPUTE RESOLUTION

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