Archive for the ‘Drug Safety Information Podcasts’ category
Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product
• Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a ground product. • The product is not […]
FDA approves imaging drug Amyvid
Estimates brain amyloid plaque content in patients with cognitive decline
FDA takes steps to protect public health
The U.S. Food and Drug Administration announced today that it is taking three steps to protect public health and promote the judicious use of medically important antibiotics in food-producing animals.
Dept. of Justice enters consent decree with California seafood processor
A California seafood importer and processor has agreed to a consent decree with the FDA that prevents the company from manufacturing or distributing fish or fish products until it has corrected conditions in its seafood processing facility alleged to be contaminated with Listeria monocytogenes (L. mono) bacteria.
FDA enters consent decree with cheese producer due to Listeria contamination
A Washington state cheese processor and distributor has agreed to keep its products off the market until they are proven safe for consumption as part of a consent decree of permanent injunction with the U.S. Food and Drug Administration.
La FDA advierte a los consumidores a no comer galletas y pan tostado de marca Crispy fabricado por TWI Foods Inc., Ontario, Canadá
La compañÃa TWI Foods Inc. está retirando voluntariamente del mercado varias variedades de galletas y pan tostado (rusk) de marca Crispy. La Administración de Alimentos y Medicamentos (FDA), junto con la Agencia Canadiense de Inspección Alimentaria (CFIA) y TWI Foods Inc., están advirtiendo a la gente con alergias a la leche o almendras de no […]
FDA announces plans to pilot end-stage kidney disease technology in new program
Three products for patients with end stage renal disease (ESRD) have been chosen to participate in the FDA’s Innovation Pathway, an evolving system designed to help medical devices reach patients in a safe, timely and collaborative manner.
FDA warns consumers not to eat Crispy brand cookies and rusk manufactured by TWI Foods Inc., Ontario, Canada
TWI Foods Inc. is voluntarily recalling several varieties of Crispy brand cookies and rusk. The Food and Drug Administration (FDA) along with the Canadian Food Inspection Agency (CFIA) and TWI Foods Inc., are warning people with allergies to milk or almonds not to consume Crispy brand cookie and rusk products. The affected products contain almonds […]
Obama administration takes action to address tobacco epidemic
The U.S. Food and Drug Administration (FDA) has released two separate draft guidance documents: the first provides guidance on how companies will comply with the requirement to report on the quantities of potentially harmful chemicals in tobacco products, and the second provides guidance to companies that seek to advertise or market a tobacco product as […]
FDA to discuss risks and benefits of metal-on-metal hip replacements
The U.S. Food and Drug Administration today announced that it is seeking expert scientific and clinical advice on the risks and benefits of metal-on-metal (MoM) hip systems as well as potential patient and practitioner recommendations on the use of MoM hip systems and the management of patients implanted with such devices. FDA will discuss these […]
FDA pursues enforcement action against California fish processor
The U.S. Food and Drug Administration, in a complaint filed by the Department of Justice, is seeking to stop the processing and distribution of fish products at a California company because of a risk of botulism and other food hazards. If granted, the permanent injunction against Fujino Enterprises Inc., doing business as Blue Ocean Smokehouse, […]
U.S. Marshals seize unapproved and misbranded drug products at Missouri distributor
Dara Corrigan, associate commissioner for regulatory affairs for the U.S. Food and Drug Administration, and David M. Ketchmark, Acting U.S. Attorney for the Western District of Missouri, announced today that U.S. Marshals have seized drugs being held by Notions-n-Things Distribution of Bogard, Mo.
New FDA guidance on considerations used in device approval, de novo decisions
The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review.
FDA approves Omontys to treat anemia in adult patients on dialysis
The U.S. Food and Drug Administration today approved Omontys (peginesatide) to treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD).
FDA approves additional blood test for viruses linked to leukemia, neurologic diseases
Avioq HTLV-I/II Microelisa System, a test designed to detect antibodies to viruses in donors of human blood and blood components that are associated with several diseases, including some forms of leukemia and neurologic diseases, was approved today by the Food and Drug Administration.
FDA approves LINX Reflux Management System to treat gastroesophageal reflux disease
The Food and Drug Administration today approved the LINX Reflux Management System for people diagnosed with gastroesophageal reflux disease (GERD) who continue to have chronic symptoms, despite the use of maximum medical therapy for the treatment of reflux.
FDA approves first Boniva generics to treat or prevent osteoporosis
The U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.