FDA reaches agreement with automatic external defibrillator manufacturer over quality control issues
Category Archives: Food Safety News
Rucker’s Makin’ Batch Candies Issues Food Recall of Dark Chocolate Coffee Beans, Dark Chocolate Cranberries and Dark Chocolate Peanuts – Because of Possible Health Risk, Due to Undeclared Milk Allergen
Rucker’s Makin’ Batch Candies, Inc. of Bridgeport, IL is voluntarily recalling the specific code dates listed below of The Toothsome Chocolate Emporium Dark Chocolate Coffee Beans, due to an undeclared milk allergen. People who have an allergy or severe sensitivity to milk allergen run the risk of serious or life threatening allergic reaction if they consume this product. No illness has been reported to date.
Read The Complete Story!
Allergy Alert Issued in Five Northern California Whole Foods Market Stores for Undeclared Walnuts in Pumpkin Drop Cookies
Five Whole Foods Market stores in Northern California are voluntarily recalling frosted Pumpkin Drop cookies because the products contained tree nut allergens (walnuts) that were not listed on the product label. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reactions if they consume these products.
Read The Complete Story!
FDA approves new treatment for adults with mantle cell lymphoma
The U.S. Food and Drug Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.
FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections
The U.S. Food and Drug Administration has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new strategies for addressing the crisis of opioid addiction through innovation in packaging, storage and disposal
Statement by FDA Commissioner Gottlieb on new strategies for addressing the opioid addiction crisis.
Statement from Susan Mayne, Ph.D., on proposal to revoke health claim that soy protein reduces risk of heart disease
Statement from Susan Mayne, Ph.D., on proposal to revoke health claim that soy protein reduces risk of heart disease
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s important efforts to address the opioid crisis
Today the Administration took a historic step to direct additional resources to help address the staggering human and economic toll created by the epidemic of opioid addiction.
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies
Enabling patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness is a core part of our mission. We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year. While we’ve unveiled parts of that plan already, we’ll be releasing its full detail shortly. As one part of that effort, we’re announcing some additional steps we’re taking right now to promote beneficial medical device innovation.