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FDA Debars Liang

03/06/2013

Federal Register Notice: FDA is issuing an order under the FD&C Act permanently debarring Cheng Yi Liang, from providing services ...

Guidance on IDEs for Retinal Prostheses

03/06/2013

Federal Register Notice: FDA is making available a guidance: Investigational Device Exemption (IDE) Guidance for Retinal Prosthese...

Panel to Discuss Certain Assay Classifications

02/27/2013

Oncologic Panel to Discuss NDAs for Renal Cell and Ocular Melanomas

02/27/2013

Federal Register Notice: FDA’s Oncologic Drugs Advisory Committee will meet 5/2, from 8 a.m. to 5 p.m. at FDA’s White ...

FDA Changes Time, Agenda for Science Board Meeting

02/27/2013

Panel to Discuss Titan NDA for Opioid Dependence

02/27/2013

Panel to Discuss Bausch and Lomb’s Trulign Toric IOL

02/27/2013

Federal Register Notice: FDA’s Ophthalmic Devices Panel will meet 4/8, from 8:30 a.m. to 6 p.m. at the Hilton Washington, DC...

FDA Alliance Sounds Alarm on Funding to Science Board

02/27/2013

FDA’s mission is again at risk and its responsibilities grow each year because Congress enacts new laws, but funding doesn&r...

Guidance on Device Recalls, Enhancements

02/22/2013

Review Period Set for Edwards’ Sapien Heart Valve

02/22/2013

Federal Register Notice: FDA has determined the regulatory review period for Edwards Lifesciences’ Sapien Transcatheter Hear...