FDA releases guidance with recommendations for drug manufacturers regarding good manufacturing practices and data integrity
Category Archives: Food Safety News
FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications
FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework
FDA announces new actions advancing the agency’s biosimilars policy framework
Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data
FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.
FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs
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 Issues Voluntary Recall of Specific Lots of 9Lives® Protein Plus® Wet, Canned Cat Food Due to Low Levels of Thiamine (Vitamin B1)
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.
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Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs
FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.
Accra Super Market Issues Allergy Alert On Undeclared Peanuts In ‘Suya Barbecue Seasoning’
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.
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Danone North America Issues Allergy Alert and Recall for Light & Fit Greek Crunch S’mores Flavor
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 labeled. People who have an allergy to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics