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FDA asks Forest for more info on antipsychotic

2013-11-21 22:57:57| Biotech - Topix.net

The New York company said Thursday the Food and Drug Administration indicated that additional clinical trial data would be needed.

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Companies partner to ease transition through FDA label changes

2013-11-21 01:00:00| Packaging Gateway

FoodMinds has joined with Nutrition Impact and EAS Consulting to create Food Label Compass, a service to help food and drinks companies navigate the Food and Drug Administration (FDA) overhaul of nutrition facts labels.

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Illumina's MiSeqDx Receives FDA Premarket Clearance

2013-11-20 22:14:57| Biotech - Topix.net

Nov. 19, 2013-- Illumina, Inc. today announced that it received premarket clearance from the U.S. Food and Drug Administration for the MiSeqDx system, the first high-throughput DNA sequencing analyzer to receive FDA clearance.

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Level Switch Meets FDA and Sanitary Standards

2013-11-18 22:38:00| Chemical Processing

Conductivity sensor can be used in storage, mixing and process vessels with or without an agitator, and it meets all international hygiene requirements.

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Mercks New Drug Application for an Investigational Intravenous (IV) Formulation of NOXAFIL (posaconazole) Receives FDA Priority Review

2013-11-18 14:30:00| Merck.com - Research & Development News

Dateline City: WHITEHOUSE STATION, N.J. Marketing Authorization Application also Filed with the European Medicines Agency WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational intravenous (IV) solution formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for priority review by the U.S. Food and Drug Administration (FDA). Language: English Contact: MerckMedia Contacts:Pam Eisele, 908-423-5042orRobert Consalvo, 908-423-6595orInvestor Contacts:Carol Ferguson, 908-423-4465orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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