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Consumer Information on: Abbott RealTime HCV
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Summary Information for: Abbott RealTime HCV
Issued May 17, 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 20, 2011
SimplyThick: Public Health Notification – Risk of Life
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Consumer Information on: VITROS® Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and Controls
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: VITROS® Immunodiagnostic Products HBeAg Reagent…
Summary Information for: VITROS® Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and Controls
Issued May 11, 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 19, 2011
Public Meeting: Ultra High Throughput Sequencing for Clinical Diagnostic Applications
The Food and Drug Administration (FDA) is announcing a public meeting Ultra High Throughput Sequencing for Clinical Diagnostic Applications – Approaches to Assess Analytical Validity. The purpose of the meeting is to discuss challenges in assessing analytical performance for ultra high throughput genomic sequencing-based clinical applications. Date, Time and Location Federal Register Notice Agenda Registration…
Chantix: Quarterwatch Article
May 19, 2011 FDA Statement In 2006, the Pfizer product, Chantix (varenicline), was FDA-approved as a smoking cessation aid. Soon after marketing, FDA became aware through its postmarketing surveillance system, the Adverse Events Reporting System or AERS, of the potential for serious neuropsychiatric events in patients taking Chantix. Subsequently, FDA began communicating about these potential…
FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData SummaryReferences  September 23, 2010.  FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products. The REMS, called the Avandia-Rosiglitazone…
Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.Document issued on: May 18, 2011. You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management…