This update is in follow-up to the FDA Communication about an Ongoing Safety Review of Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder (ADHD). Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [12-12-2011] The U.S. Food and Drug Administration (FDA) is updating its communication on the ongoing cardiovascular safety review…
Summary Information for: PROMUS® Element? Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail? and Over-The-Wire)
Issued November 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 December 9, 2011
Consumer Information on: PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System
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Consumer Information on: HER2 CISH pharmDx? Kit
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Summary Information for: HER2 CISH pharmDx? Kit
Issued November 30, 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 December 9, 2011
Class I Medical Device Recall: CooperVision AVAIRA Toric and Sphere Soft Contact Lenses
Recall Class: Class I Date Recall Initiated: August 19, 2011; expanded on November 15, 2011 Product(s): AVAIRA (enfilcon A) TORIC and SPHERE soft (Hydrophilic) Contact Lenses The Avaira Sphere Contact Lenses recall is an expansion of the Class I recall of CooperVision’s Avaira Toric Contact Lenses. Go to the CooperVision recall web page at www.coopervision.com/international-recall,…
Cord Blood Banking Information for Consumers
December 7, 2010 Expecting a baby can be a very exciting time for soon-to-be-parents. It can also be very confusing, with many decisions to make. One choice prospective parents often face is whether to donate, bank or discard their baby’s cord blood. Did you know that the Food and Drug Administration (FDA) regulates cord blood?…
CooperVision AVAIRA Toric and Sphere Soft Contact Lenses: Class 1 Recall
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Transcript for November 4, 2011 National Mammography Quality Assurance Advisory Committee Meeting
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FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [12-7-2011] The U.S. Food and Drug Administration (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial…