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FDA Science Board Discuss Opioids

02/17/2016

Federal Register Notice: The Science Board to the FDA will meet 3/1, from 8:30 a.m. until 5 p.m. at FDA’s White Oak Campus, ...

Workshop on Devices for Monitoring Warfarin Therapy

02/17/2016

Federal Register Notice: FDA will hold a public workshop 3/18 entitled “Point of Care Prothrombin Time/International Normali...

FDA Seeks Participants for Tobacco E-submissions Pilot

02/17/2016

Federal Register Notice: FDA’s Center for Tobacco Products (CTP) is soliciting applications from regulated tobacco product m...

Panel to Discuss Leadless Cardiac Pacemakers

12/14/2015

Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 2/18/16,...

Comments Sought on ‘Enhanced Transparency’ Submissions

12/10/2015

Federal Register Notice: FDA is seeking public comment on a proposed information collection involving interviews of pharmaceutical...

FDA Sets Review Period for Fulyzaq

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Napo Pharmaceuticals’ Fulyzaq is 7,784 days for...

Review Period Set for Sirturo

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Janssen Pharmaceutica’s Sirturo is 2,213 days f...

Review Period Set for Eliquis

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Bristol-Myers Squibb’s Eliquis is 3,685 days fo...

Review Period Set for Visual Stimulation System

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Second Sight Medical Products’ Argus II Visual ...

Review Period Set for Bayer Animal Health’s Veraflox

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Bayer Animal Health’s Veraflox is 3,285 days fo...