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)

The FDA today issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.

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.

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.

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.

FDA, international counterparts report progress on drug inspection collaboration

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.

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.

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.

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.