Tuesday, April 2, 2019

Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices

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Wakefern Food Corp. Voluntarily Recalls Wholesome Pantry Organic Nut Butters Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Wakefern Food Corp. has initiated a voluntary recall of a variety of Wholesome Pantry Organic nut butters because they may be contaminated with Listeria monocytogenes, 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 high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. No illnesses related to the recall have been reported.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products - FDA Press Releases

FDA is announcing a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.

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USDA, EPA, and FDA Recognize April as Winning on Reducing Food Waste Month - FDA Press Releases

The agencies kick off Winning on Reducing Food Waste Month by calling for greater collaboration with public, private, and nonprofit partners as well as state and local officials.

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FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids - FDA Press Releases

Agency issued two warning letters to operators of websites that illegally market potentially dangerous, unapproved and misbranded opioid medications.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access - FDA Press Releases

FDA is announcing a public hearing to discuss access to affordable insulin products.

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Monday, April 1, 2019

NadaMoo! Voluntarily Recalls Select Pints of Strawberry Cheesecake Due to Undeclared Almond - FDA Safety Alerts & Drug Recalls

Little Red Rooster Ice Cream Company, d/b/a NadaMoo! (“NadaMoo!”) announced a limited voluntary recall of approximately 26,000 pints of its Strawberry Cheesecake Non-Dairy Frozen Dessert because they contain an undeclared almond ingredient. People who have an allergy or severe sensitivity to almonds run the risk of a serious or life-threatening allergic reaction if they consume the recalled products.

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