: El día de hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) tomó una medida importante para proteger mejor a los consumidores de los peligros de los productos de cafeína altamente concentrada y pura.
Today, the U.S. Food and Drug Administration took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products.
The FDA today finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments.
FDA permits marketing of first medical device to use artificial intelligence to detect greater than a mild level of diabetic retinopathy in the eye of adults who have diabetes.
FDA clears first contact lens with additive that automatically darkens the lens when exposed to bright light
Stewart’s Shops Corp. is recalling units of Stewart’s pint Chocolate Peanut Butter Cup ice cream because they may have been packaged incorrectly with a “Chocolate” lid. People who have an allergy to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product. Read The Complete Story!
FDA is restricting the sale and distribution of the Essure device to only those health care providers who provide information to women about the risks and benefits of this device before they get the permanent contraception implant.
Bob’s Red Mill Natural Foods is voluntarily recalling 2,099 cases of Organic Amaranth Flour (22 oz.), after recent testing revealed the presence of Salmonella in a single LOT of Organic Amaranth Flour (22 oz.) with a Sell By date of Nov. 26, 2015. Read The Complete Story!
Izzy’s Ice Cream, LLC is voluntarily recalling limited numbers of its Maple Nut Ice Cream pints following a supplier’s recall of walnuts due to the possible presence of undeclared peanut residue. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products […]
Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct […]
FDA announces an enforcement action taken against Vulto Creamery of New York. The company cannot sell ready-to-eat raw cheese product until it complies with the consent decree. Vulto was linked to an outbreak last year.
FDA issues update to Benefit-Risk Assessment plan as part of efforts to enhance the patient perspective and experience in drug development and review
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
A New York dietary supplement manufacturer has been ordered by a federal court to stop selling its products until the company comes into compliance with the FDA’s dietary supplement manufacturing regulations.
Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs
The authorization classifies integrated continuous glucose monitoring devices in class II and subjects them to certain criteria called special controls
Tamarack Inc. of Roy, Utah is voluntarily recalling Eclipse Kratom-containing powder products because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which […]
King Arthur Flour Company is voluntarily recalling a limited quantity (6,300 cases) of Organic Coconut Flour (16 oz.), after testing revealed the presence of Salmonella in 1 pouch of Organic Coconut Flour (16 oz.). Read The Complete Story!
The J.M. Smucker Company today announced a limited, voluntary recall of specific lots of two varieties of Milo’s Kitchen® dog treats, distributed nationally, because the products potentially contain elevated levels of beef thyroid hormone. Read The Complete Story!