Advisory Committee Meeting – Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

What: Discuss/Recommend clinical trial, postapproval study design, and physician training requirements for leadless cardiac pacemaker device technology.

When: February 18, 2016

Where: Hilton Washington DC

Who : Dimitrus.Culbreath@fda.hhs.gov


 

Public Workshop – Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy

What: Analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy

When:  January 25, 2016

Where:  FDA White Oak Campus

Who : Registration


JANUARY 2016 MEETINGS : ROUNDUP

Psychopharmacologic Drugs Advisory Committee Meeting (Jan 12)

NDA 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant for proposed indication of maintenance treatment of opioid dependence  More information

Vaccines and Related Biological Products Advisory Committee Meeting (Jan 14)

Research  updates from Division of Viral Products, CBER, FDA.  More information

Public Workshop – Moving Forward: Collaborative Approaches to Medical Device Cybersecurity (Jan 21-22)

Details posted previously. Medical device cybersecurity  More information

Public Workshop – Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy (Jan 25)

Posted above

The Twentieth FDA CASSS Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products  (Jan 26)

Latest bio-analytical methods and practical applications. More information


 

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