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Partner Series – Global Strategies to Substantiate and Support Supplement Claims

Posted by Toxicology News on Monday Aug 15, 2011 Under News

Ray A. Matulka, Ph.D., Director of Toxicology; Douglas L. Marshall, Ph.D., Chief Scientific Officer, Microbiology; Jules Skamarak, Business Unit Manager, Eurofins INSIDER Partner Series Companies developing and distributing food and nutritional products for US and international markets face multiple challenges, the most challenging being … (more)

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FDA seeks comment on proposed guidelines for high-quality clinical studies

Posted by Food and Drug Administration--Press Releases on Monday Aug 15, 2011 Under News

The FDA today issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.

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FDA, state of Arkansas sign agreement to advance regulatory science

Posted by Food and Drug Administration--Press Releases on Friday Aug 12, 2011 Under News

An agreement to establish a virtual Center of Excellence for Regulatory Science was signed today between the U.S. Food and Drug Administration’s National Center for Toxicological Research (NCTR) and the state of Arkansas.

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FDA approves the first specific treatment for scorpion stings

Posted by Food and Drug Administration--Press Releases on Wednesday Aug 3, 2011 Under News

The U.S. Food and Drug Administration today approved Anascorp, the first specific treatment for a scorpion sting by Centruroides scorpions in the United States.

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Brote de origen alimentario podría estar relacionado con la papaya distribuida por Agromod Produce, Inc.

Posted by Food and Drug Administration--Press Releases on Wednesday Aug 3, 2011 Under News

La FDA está tomando medidas para proteger al público tras la identificación de Salmonella Agona en las papayas frescas distribuidas por Agromod Produce, Inc. La FDA está aconsejando a los consumidores a no comer papayas vendidas por Agromod Produce, Inc. La compañía está retirando voluntariamente del mercado el producto. Las papayas fueron importadas de México y es posible que estén relacionadas con los casos reportados de Salmonella Agona. Las pruebas recientes realizadas por la FDA encontraron la cepa del brote en dos muestras de papaya: una proveniente de la instalación de Agromod Produce, Inc., en McAllen, Texas, y la otra tomada en la frontera de EE.UU. y destinada a Agromod Produce, Inc. Los lotes que dieron resultados positivos a la cepa del brote no fueron distribuidos en EE.UU.

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FDA, international counterparts report progress on drug inspection collaboration

Posted by Food and Drug Administration--Press Releases on Tuesday Aug 2, 2011 Under News

FDA, international counterparts report progress on drug inspection collaboration

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FDA reopens comment period on proposed ‘gluten-free’ food labeling rule

Posted by Food and Drug Administration--Press Releases on Tuesday Aug 2, 2011 Under News

The U.S. Food and Drug Administration today reopened the comment period for its 2007 proposal on labeling foods as “gluten-free.” The agency is also making available a safety assessment of exposure to gluten for people with celiac disease (CD) and invites comment on these additional data.

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FDA to seek public comment on IOM recommendations

Posted by Food and Drug Administration--Press Releases on Friday Jul 29, 2011 Under News

The FDA today announced that it will open a public docket to begin receiving public comments on the Institute of Medicine’s (IOM) report on the 510(k) program, the most common pathway to market for lower-risk medical devices.

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Unapproved emergency birth control medicine possibly in U.S. distribution may be ineffective and unsafe

Posted by Food and Drug Administration--Press Releases on Thursday Jul 28, 2011 Under News

The U.S. Food and Drug Administration (FDA) is warning U.S. consumers not to use the emergency birth control medicine labeled as Evital. These products may be counterfeit versions of the “morning after pill” and may not be safe or effective in preventing pregnancy.

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Unapproved emergency birth control medicine possibly in U.S. distribution may be ineffective and unsafe

Posted by Food and Drug Administration--Press Releases on Thursday Jul 28, 2011 Under News

The U.S. Food and Drug Administration (FDA) is warning U.S. consumers not to use the emergency birth control medicine labeled as Evital. These products may be counterfeit versions of the “morning after pill” and may not be safe or effective in preventing pregnancy.

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