Category Archives: Drug Safety Information Podcasts

Foodborne outbreak potentially associated with papaya distributed by Agromod Produce, Inc.

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.

FDA, federal partners develop tools for food-emergency readiness

The U.S. Food and Drug Administration and federal partners today released the Food Related Emergency Exercise Boxed (FREE-B) set, a Web-based collection of scenarios that will help government regulators, public health organizations and the food industry test their readiness for food-related emergencies, such as a human health emergency caused by an unintentional contamination of produce with E. coli O157:H7.

FDA outlines oversight of mobile medical applications

The U.S. Food and Drug Administration today announced it is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications (“apps”) that are designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets.

FDA seeks comment on proposed policy for diagnostic tests used with targeted drug therapies

The U.S. Food and Drug Administration today issued a new draft guidance to facilitate the development and review of companion diagnostics – tests used to help health care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft document is intended to provide companies with guidance on the agency’s policy for reviewing a companion diagnostic and the corresponding therapy.