FDA Alerts
FDA Wants Breakthrough Ideas for Finding Foodborne Illness
The U.S. Food and Drug Administration is asking for potential breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce.
FDA Allows Marketing of Blood Test for Five Yeast Pathogens
The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei.
FDA Unveils Plans to Prevent Foodborne Illness
Based on extensive outreach and public comment, the U.S. Food and Drug Administration today proposed revisions to four proposed rules designed to help prevent food-borne illness.
FDA Approves Movantik for Opioid-Induced Constipation
The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.
FDA Advises Consumers Not to Use Weight Loss Supplement
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Best Line Suplemento Alimenticio Capsules, a product promoted and sold for weight loss on various websites and in some retail stores.
Mezo Contains Hidden Drug Ingredient
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Mezo, a product promoted and sold for weight loss on various websites and in some retail stores.
LX1 Contains Hidden Drug Ingredient
The Food and Drug Administration (FDA) is advising consumers not to purchase or use LX1, a product promoted and sold for weight loss on various websites, including Dr. Skin Secretsdisclaimer icon, and possibly in some retail stores.
FDA Reminds Public of Safety Concerns With Downing Labs Products
The U.S. Food and Drug Administration is reminding health care professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas, Texas.
FDA Allows Marketing of Kidney Injury Test
Today the U.S. Food and Drug Administration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the administration of the test.
U.S. Marshals Seize Drug Products from Flawless Beauty
Various unapproved and improperly labeled drug products that were marketed, sold and distributed via the Internet by Flawless Beauty LLC, of Asbury Park, New Jersey, have been seized by U.S. Marshals.