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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...

Guidance on National Drug Code Numbers for Devices

02/03/2016

Federal Register Notice: FDA makes available a draft guidance for industry and FDA staff entitled Enforcement Policy on National H...

Info on Tobacco Product Research Sent to OMB

02/03/2016

Federal Register Notice: FDA’s proposed collection of information, “Guidance on Meetings with Industry and Investigato...

OMB OKs Info on Non-Rx Drug Adverse Event Reporting

02/03/2016

Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on Postmarketing Adverse Even...

Guidance on Human Factors Data for Devices

02/03/2016

Federal Register Notice: FDA is making available a draft guidance entitled List of Highest Priority Devices for Human Factors Revi...

OMB OKs Info on Biosimilar User Fee Cover Sheet

02/03/2016

Federal Register Notice: FDA’s collection of information entitled “Biosimilar User Fee Cover Sheet; Form FDA 3792,&rdq...

Info on Postmarketing Adverse Drug Reporting Sent to OMB

02/03/2016

Federal Register Notice: FDA’s collection of information entitled “Postmarketing Adverse Drug Experience Reporting&rdq...

Guidance on Applying Human Factors to Devices

02/03/2016

Federal Register Notice: FDA is making available a guidance entitled Applying Human Factors and Usability Engineering to Medical D...

Guidance on Human Factor Studies for Combo Products

02/03/2016

Federal Register Notice: FDA is making available a draft guidance for industry and FDA staff entitled Human Factors Studies and Re...