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Guidance on Benefit-Risk Considerations for Device Enforcement

06/16/2016

Federal Register Notice: FDA is making available a draft guidance entitled Factors to Consider Regarding Benefit-Risk in Medical D...

Guidance on ISO Biological Evaluation of Devices

06/16/2016

Federal Register Notice: FDA is making available a guidance entitled Use of International Standard ISO 10993-1, `Biological evalua...

Pediatric Clinical Investigator Workshop

06/16/2016

Federal Register Notice: FDA’s Office of Pediatric Therapeutics, and the Eunice Kennedy Shriver National Institute of Child ...

Pediatric Oncology Subcommittee to Meet

06/16/2016

Federal Register Notice: FDA will hold a meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee6...

Comments Sought on Biologic and HCT/P Deviations Reporting

06/07/2016

Federal Register Notice: FDA is seeking public comment on the information collection requirements relating to the reporting of bio...

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,...

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...