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.

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.

FDA, international counterparts report progress on drug inspection collaboration

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The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.

The FDA is taking steps to protect the public following the identification of Salmonella Agona in Agromod Produce, Inc.’s supply of fresh papayas. The FDA is advising consumers not to eat papayas from Agromod Produce, Inc. The company is voluntarily recalling the product. The papayas were imported from Mexico, and may be linked to the reported cases of Salmonella Agona. Recent sampling by the FDA found the outbreak strain in two papaya samples: one collected at the Agromod Produce, Inc. location in McAllen, Texas, and one collected at the U.S. border destined for Agromod Produce, Inc. The shipments that tested positive with the outbreak strain were not distributed in the U.S.

A U.S. Food and Drug Administration report from its Center for Drug Evaluation and Research (CDER), available today in the Federal Register, identifies the current regulatory science needs that will guide CDER’s strategic planning of internal research initiatives and contributions to the development of agency regulatory science efforts.

The U.S. Food and Drug Administration today approved the blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).