FDA BRIEF: Week of March 6, 2017
1Q2017 MDUFA III PERFORMANCE METRICS
Metrics for Draft Guidances, PMA, 510(k), IDE posted
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
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
FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction
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