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 approves imaging drug Amyvid
Estimates brain amyloid plaque content in patients with cognitive decline
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 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.
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 and/or milk which are not clearly declared on the label.
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The U.S. Food and Drug Administration (FDA) has released two separate draft guidance documents: the first provides guidance on how companies will comply with the requirement to report on the quantities of potentially harmful chemicals in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 less harmful or associated with reducing the risk of tobacco-related disease.
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, of Half Moon Bay, Calif., would stop the company from processing and distributing fish and fish products.
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.
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 issues at a two-day expert advisory panel meeting on June 27-28, 2012.
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.