HEALTH

PacificHealth to develop sports nutrition product with Signal Nutrition’s help

BY Michael Johnsen

MATAWAN, N.J. PacificHealth Labs plans to introduce innovation within the sports nutrition category, the company announced Friday, with the signing of Signal Nutrition as a consultant.

“[Signal Nutrition] brings a wealth of knowledge and experience in assisting [PacificHealth] address its core needs in the area of science and the development of new products,” stated Fred Duffner, Pacifichealth president. “The company has not provided new innovation under its sports nutrition umbrella in over 3 years,” he said. “There is new science in the category that we need to stay ahead of to insure we continue to bring leadership to the category. We look forward to working with [Signal Nutrition] over the next several months to prepare for 2011 and the anticipated growth opportunities.”

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Bayer Diabetes Care updates devices under National Glycohemoglobin Standardization Program

BY Michael Johnsen

TARRYTOWN, N.Y. Bayer Diabetes Care has successfully completed certification of its A1CNow+ and A1CNow Selfcheck devices under a tighter performance certification standard that went into effect Jan. 1.

The new performance certification standards applicable to devices that measure A1C (or glycated hemoglobin) as set by the National Glycohemoglobin Standardization Program (NGSP) changed to +/-0.75% A1C, 95% CI, 4-10.0% A1C range.

Bayer received a new NGSP certificate valid from July 1, 2010 through July 1, 2011.  The previous criteria for last year’s NGSP certification was +/-0.85% A1C, 95% CI, 4-12.0% A1C range.

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FDA issues warning letter to Abbott Diabetes Care manufacturing plant

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration earlier this week posted a July 2 warning letter addressing quality concerns at an Abbott Diabetes Care manufacturing plant.

The warning letter outlined some of the specific violations of good manufacturing practices for the manufacturer of the FreeStyle blood glucose meter, including not following through on reports concerning empty blister packs being produced on the Noack Blister Packer at one of Abbott’s establishments. Similarly, an exception report initiated on April 8, 2008, for scratches on FreeStyle Lite strips was closed with no corrective action or effectiveness check, the agency stated.

Abbott is working with the FDA to address the agency’s concerns.

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