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International Regulatory News

FDA takes steps to protect public health Agency working with animal, drug and medical communities to promote judicious antimicrobial use
2012-04-11 00:00:00
The U.S. Food and Drug Administration announced today that it is taking three steps to protect public health and promote the judicious use of medically important antibiotics in food-producing animals. Antimicrobial resistance occurs when bacteria... 

Department of Justice enters consent decree with California seafood processor Company agrees to multiple actions to correct FDA food safety violations
2012-04-11 00:00:00
A California seafood importer and processor has agreed to a consent decree with the FDA that prevents the company from manufacturing or distributing fish or fish products until it has corrected conditions in its seafood processing facility alleged to... 

FDA announces plans to pilot end-stage kidney disease technology in new program
2012-04-10 00:00:00
Innovation Pathway aims to reduce time and cost of bringing safe and effective, breakthrough technologies to patients Three products for patients with end stage renal disease (ESRD) have been chosen to participate in the FDA's Innovation Pathway, ... 

Akron Rubber Development Laboratory, Inc's Time Domain (TD) Nuclear Magnetic Resonance (NMR) Capabilities Expand to Help Meet Today's Quality Assurance Needs
2012-04-09 00:00:00
Akron, OH - Determining the state of cure of elastomeric materials is becoming more and more important to today's material development companies and parts manufacturers. Quality Assurance Managers, Production Managers and Material Development Engine... 

Akron Rubber Development Laboratory, Inc Adds to Its Accreditation Independent High Pressure / High Temperature Aging, Rapid Gas Decompression (RGD) Testing and Service Life Prediction Capabilities for Materials Used in the Oil and Gas Industry
2012-04-09 00:00:00
Akron, OH - Polymer engineering and material qualification for oil and gas applications is a daily challenge for engineers as they deal with ever higher pressures and temperatures at new depths and in new gases. Akron Rubber Development Laboratory,... 

FDA enters consent decree with cheese producer due to Listeria contamination
2012-04-09 00:00:00
Washington state cheese processor agrees to FDA food safety action A Washington state cheese processor and distributor has agreed to keep its products off the market until they are proven safe for consumption as part of a consent decree of permane... 

CLSI Publishes Revised Guideline on Nucleic Acid Amplification Assays for Molecular Hematopathology
2012-04-05 00:00:00
The Clinical and Laboratory Standards Institute (CLSI) recently published Wayne, Pennsylvania, USA-April 2012-Clinical and Laboratory Standards Institute (CLSI) recently published Nucleic Acid Amplification Assays for Molecular Hematopathology; Appro... 

FDA proposes lower risk classification for certain tuberculosis tests
2012-04-04 00:00:00
Lower classification will support CDC recommendations The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis (TB). This rule would lower the current... 

Avomeen Analytical Services Renews Registration with Contract Laboratory .com
2012-04-03 00:00:00
Contract Laboratory Inc. is pleased to announce that Avomeen Analytical Services has become a member of its Laboratory Outsource Network - ContractLaboratory.com. Avomeen Analytical Services is a full-service chemical testing laboratory specializi... 

ARDL's Time Domain (TD) Nuclear Magnetic Resonance (NMR) Capabilities Expand to Help Meet Today's Quality Assurance Needs
2012-04-02 00:00:00
For Immediate Release: April 2, 2012 From: 2887 Gilchrist Road Akron, OH 44305 p.330.794.6600 f.330.794.6610 www.ardl.com ARDL's Time Domain (TD) Nuclear Magnetic Resonance (NMR) Capabilities Expand to Help Meet Today's Quality A... 

Ramboll Finland Registers with Contract Laboratory .com
2012-04-02 00:00:00
Contract Laboratory Inc. is pleased to announce that Ramboll Finland has become a member of its Laboratory Outsource Network - ContractLaboratory.com. Ramboll is a truly multi-disciplinary engineering, design and consultancy company working to mee... 

New FDA guidance on considerations used in device approval, de novo decisions
2012-04-01 00:00:00
Clinical data, risks, benefits and patient risk tolerance outlined in process The U.S. Food and Drug Administration today published a first-of-a-kind guidance1 for medical device manufacturers, describing how the benefits and risks of certain medi...