Remarks by FDA’s Anna Abram to the 2018 Intergovermental Meeting on Drug Compounding
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FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases
Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey
Purus Labs, Inc of Plano, Texas is recalling MyoWhey Chocolate Cookie Crunch,
because it may contain undeclared milk and soy. This only effects products with Lot
number PL: 0100518 Exp: 04/2020. People who have an allergy or severe sensitivity to
milk and soy run the risk of serious or life-threatening allergic reaction if they consume
these products.
Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters
Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of Cyclospora
he safety of the American food supply is one of the U.S. Food and Drug Administration’s highest priorities. A key part of our work in this space focuses on implementing the principles and measures of the FDA Food Safety Modernization Act (FSMA). The actions directed by FSMA are designed to prevent foodborne illness and food safety problems from happening.
FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications
FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications.
Lidl Voluntarily Recalls Bellona Brand Hazelnut Wafers Due to Improperly Declared Wheat Allergen
Lidl US has voluntarily recalled all Bellona brand “Milk Chocolate Flavored Coated Wafer with Hazelnut Crème Filling and White Chocolate Flavor” confections as a precautionary measure because the allergen statement does not include wheat.
Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids
Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids.
FDA launches new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids
FDA launched new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids.
FDA approves device for treatment of acute coronary artery perforations
FDA approves device for treatment of acute coronary artery perforations