The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.
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 approves blood-thinning drug Brilinta to treat acute coronary syndromes
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).
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 approves vaccines for the 2011-2012 influenza season
The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United States.
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.
Foodborne outbreak associated with raw milk from Tucker Adkins Dairy of York S.C.
The FDA is warning consumers not to drink raw milk from Tucker Adkins Dairy of York, S.C. Three confirmed cases and five probable cases of campylobacteriosis in North Carolina are associated with raw milk from Tucker Adkins Dairy.
FDA: Surgical placement of mesh to repair pelvic organ prolapse poses risks
The U.S. Food and Drug Administration today issued an updated safety communication warning health care providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options.
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.
FDA approves Boostrix to prevent tetanus, diphtheria, and pertussis in older people
The U.S. Food and Drug Administration today approved Boostrix vaccine to prevent tetanus, diphtheria, and pertussis (whooping cough) in people ages 65 and older.