What is FDA Posting? Why is FDA posting this summary information? What information is provided on this web site? What information does FDA consider for these postmarketing safety evaluations? How is the information analyzed? Postmarketing Drug Safety Evaluation Summaries October 2010 – December 2010 January 2010 – September 2010 Â Â What is FDA posting? This…
Minutes from Stakeholder Meeting on MDUFA III Reauthorization, April 27, 2011
Stakeholder Meeting on MDUFA III ReauthorizationApril 27, 2011, 1:30 – 3:30 PMHHS Humphrey Building, Washington, DCRoom 305A Purpose To discuss FDA’s proposal package presented to Industry for MDUFA III. Participants Meeting Start Time: 1:45 pm Background FDA recently presented a proposal package for MDUFA III to Industry. The goal of the package is to achieve…
Consumer Information on: ION? Paclitaxel-Eluting Coronary Stent System
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Summary Information for: ION? Paclitaxel-Eluting Coronary Stent System
Issued April 22, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated May 12, 2011
Agenda and Materials From May 4, 2011 FDA MDUFMA / MDUFA Performance Report (PDF)
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Consumer Information on: AcrySof® Toric Intraocular Lens – (IOL)
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Summary Information for: AcrySof® Toric Intraocular Lens (IOL)
Issued May 3, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated May 12, 2011
Fluzone, Fluzone High-Dose and Fluzone Intradermal
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Class I Medical Device Recall: Defibtech LLC, Lifeline and ReviveR AEDs: Software Defect May Cancel Shock
Recall Class: Class I Date Recall Initiated: March 14, 2011 Product: Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. 65,885 AEDs distributed in the United States are subject to this recall. Defibtech will provide customers with a free software upgrade. Because the conditions that may lead…
Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes: SelectSecure Model 3830 Lead
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