Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds
The FDA provides update on Essure postmarket review study as company prepares to halt sales of the device on December 31.
FDA alerted parents, caregivers and health care providers to the safety risks that jewelry used for relieving teething pain pose for children.
FDA sends warning letter to Genetech, Inc. and letters to other companies to reiterate the FDA’s compliance and enforcement policy regarding stem cells.
FDA announces steps being taken on two medical device programs: finalizing guidance on the Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).
FDA’s 2017 report of sales/distribution data for antimicrobial drugs for food animals showed a continued decline in sales, a reflection of improved antimicrobial stewardship
Saranac Brand Foods, Inc. specialized in a variety of 35 different ready-to-eat foods, including prepared salads, dips, and sauces.
Inspired Organics, LLC has issued a voluntary recall of Organic Almond Butter due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as […]
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation
FDA announces withdrawal of the proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
FDA releases guidance with recommendations for drug manufacturers regarding good manufacturing practices and data integrity
FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.
FDA announces new actions advancing the agency’s biosimilars policy framework
FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.
FDA clears a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder
The J.M. Smucker Company today announced a voluntary recall of specific lots of 9Lives® Protein Plus® wet, canned cat food due to possible low levels of thiamine (Vitamin B1). No illnesses related to this issue have been reported to date and the product is being recalled out of an abundance of caution. Read The Complete […]
FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.
Accra Super Market of Worcester MA, is recalling 0.53 lbs packages of “Suya Barbecue Seasoning” because it may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product. Read The Complete Story!
Danone North America is voluntarily recalling 3,521 cases of Light & Fit® Greek Crunch Nonfat Yogurt & Toppings S’Mores Flavor sold in the United States with an expiration date of December 30, 2018 and UPC of 36632 03825. It was discovered that some of the toppers sold on the product contain peanuts and are improperly […]