Tag: FDA


   News

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HPLC Analyzer Cleared by FDA for Diagnosis of Diabetes3 Feb 2014Read
FDA Approves TRETTEN® for the Treatment of Congenital Factor XIII A-Subunit Deficiency8 Jan 2014Read
Corgenix Announces Filing of 510(k) Premarket Notification for FDA Clearance of TxBCardio™ Assay17 Dec 2013Read
Illumina’s MiSeqDxTM Receives FDA Premarket Clearance with Two Cystic Fibrosis Assays and Universal Kit for Open Use19 Nov 2013Read
Corgenix Files Concurrent de novo 510(k) Pre-Market Notification for FDA Clearance of its Hyaluronic Acid (HA) Test Kit13 Nov 2013Read
New Webinar Announcement - Biosimilar Characterization: Leveraging Protein Analytical Technology Within GMP Guidelines to Design a Pathway to a Successful Product3 Oct 2013Read
Luminex Corporation Receives FDA and European Clearance for a New Personalized Medicine Genotyping Assay26 Sep 2013Read
FDA Clearance Recieved For QuantStudio Dx Molecular Diagnostic Tests17 Sep 2013Read
Quidel Receives Two FDA Clearances for Molecular Diagnostic Tests for Use on Life Technologies QuantStudio™ Dx16 Sep 2013Read
Manufacturer of Rapid Influenza Tests Agrees with Proposed New Standards to Improve Test Performance27 Aug 2013Read

  Application Articles

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Unraveling the Exclusivity Determination for Prodrugs12 May 2014Read
A Model for Pharmaceutical Supply Chain Quality Agreements7 Mar 2014Read
Laser Diffraction and Automated Imaging: Complementary Techniques for Nasal Spray3 Mar 2014Read
Vero Cell-based Vaccine Production: Rabies and Influenza Cell lines, Media and Bioreactor Options26 Feb 2014Read
Rapid, Reliable Metabolite Ratio Evaluation for MIST Assessments in Drug Discovery and Preclinical Studies12 Dec 2012Read
An In Silico Test Battery For Rapid Evaluation of Genotoxic and Carcinogenic Potential of Chemicals9 Apr 2012Read

  Video

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Analysis of Dietary Supplements5 Nov 2012Watch