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 : [email protected]
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
2015 REVIEWS : Good Reads