FDA BRIEF: Week of September 19, 2016

FDA launches NALOXONE APP COMPETITION 

Image result for 2016 Naloxone App Competition,

  • Public contest on developing innovative technologies to combat opioid overdose epidemic
    1. For: Computer programmers, public health advocates, clinical researchers, entrepreneurs, innovators from all disciplines
    2. Create: App to connect opioid users experiencing overdose with nearby naloxone (antidote) carriers
  • Goal to develop a low-cost, scalable, crowd-sourced App to increase accessibility
  • Registration Deadline : Oct. 7, 2016
  • Code-a-thon: Oct. 19-20, 2016, @ FDA campus
    1. Code: Open-source, publicly accessible; collaboration
  • Submission Deadline: Nov. 7, 2016. Submit video of functional prototype along with concept summary
  • Judging: FDA, NIDA, and SAMHSA
  • Award:  $40,000 + application for NIDA SBIR grant

CDRH REGULATORY SCIENCE PRIORITIES (FY2017)

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  • Leverage “Big Data” for regulatory decision-making
  • Modernize biocompatibility and biological risk evaluation of device materials
  • Leverage real-world evidence in regulatory decision-making
  • Advance methods for predicting/monitoring medical device clinical performance
  • Improve and streamline clinical trial design
  • Develop computational modeling technologies  for regulatory decision-making
  • Enhance performance of Digital Health and strengthen medical device cybersecurity
  • Reduce healthcare associated infections by better understanding antimicrobials, sterilization, reprocessing of medical devices
  • Collect and use patient input in regulatory decision-making
  • Leverage precision medicine and biomarkers for predicting medical device performance, disease diagnosis and progression

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National Evaluation System for health Technology (NEST) Report

Image result for A NEST Planning Board Report

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NEST

  • Collaborative system leverages real-world evidence from  different sources (see above) to better understand how medical devices perform
  • Contribute to regulatory decisions, promote device innovation, provide timely and meaningful information directly to patients and health care providers

THIRD REPORT

  • Published by  Duke-Margolis Center for Health Policy through cooperative agreement with FDA
  • Goals for Phase 1
    1. Balancing of pre- and postmarket device evidence development
    2. Active surveillance system
  • Goals for Phase 2
    1. Class 2 devices: Enhanced data collection and integrating health IT systems
    2. Patient-mediated data sharing
    3. Measuring device value

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FINAL RULE on ClinicalTrials.gov REQUIREMENTS

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Final rule on requirements for registering certain clinical trials and summary results  to ClinicalTrials.gov.

Legal requirements for submitting registration and results information for clinical trials involving FDA -regulated drug, biological and device products.

  • Access is good for patients, the public and science
  • Maximize value of clinical trials
  • Honor commitments to trial participants

Key elements:

  • Checklist for trial eligibility and responsibility
  • Expanded scope for summary results information
  • Additional registration and summary results information data –  race, ethnicity of trial participants, if collected, and the protocol
  • Additional types of adverse event information
  • List of potential legal consequences for non-compliance.

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