FDA BRIEF: Week of March 6, 2017

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1Q2017 MDUFA III PERFORMANCE METRICS

Metrics for Draft Guidances, PMA, 510(k), IDE posted

PMA

510k

IDE

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CDER – Moving forward in 2017

Main 2017 Priorities

  • Improving and implementing Informatics Process Management
  • Implementing recent provisions of the 21st Century Cures Act
  • Providing technical assistance to reauthorization of various User Fee bills
  • Executing action plan for combating opioid epidemic
  • Modernizing assessment of manufacturing facilities and mutual reliance initiative with EU
  • Controlling harm from pharmacy compounding

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Significant 2016 Achievements

  • Good performance of GDUFA
  • Substantive steps in biosimilar regulation
  • User Fee negotiations
  • Integrating sentinel system with OSE and Safety Surveillance
  • Implementing provisions of various statutes: Sunscreen Innovation Act, Patient-Focused Meetings, Patient-Focused Drug Development meetings in rare disorders

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Alert the health care professionals and patients about  Transvascular Autonomic Modulation (TVAM) – an experimental procedure 

TVAM

  • Threading catheter into  venous system, e.g. jugular vein, where balloon attached to inflate to widen vein walls

FDA Unapproved Claim:

  • At least one physician, Dr. Michael Arata‘ – uses TAVM in venous system to treat signs and symptoms of autonomic dysfunction in neurological disorders
  • FDA approval for use only in arteries
  • No FDA review of data supporting safety and effectiveness for intended use in veins

Risk to patients:

  • No clear scientific evidence to support effectiveness – impacting symptom, changing course of health condition, improving quality of life
  • Associated with serious complications: Rupture of balloon, death, blood clots, cranial nerve damage, abdominal bleeding
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