As a safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection.
As a safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection.
On Friday, Feb. 12, U.S. District Judge Jon D. Levy of the District of Maine entered a consent decree of permanent injunction against Mill Stream Corporation, doing business as Sullivan Harbor Farm, and its former president and owner, Ira J. Frantzman. The decree results from a complaint filed by the U.S. Department of Justice at […]
On Friday, Feb. 12, U.S. District Judge Jon D. Levy of the District of Maine entered a consent decree of permanent injunction against Mill Stream Corporation, doing business as Sullivan Harbor Farm, and its former president and owner, Ira J. Frantzman. The decree results from a complaint filed by the U.S. Department of Justice at […]
The U.S. Food and Drug Administration is requesting a total budget of $5.1 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2017 budget – an eight percent increase over the enacted budget for FY 2016. The overall request includes a net increase of $14.6 million in budget […]
Mahina Mele Farms, LLC is expanding a voluntary recall of its macadamia nut products within expiry after FDA testing found Salmonella in macadamia nuts. One sample from LOT 30 was found to be positive for Salmonella Give. Read The Complete Story!
In response to the opioid abuse epidemic, today Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, called for a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan will focus on policies aimed at reversing the epidemic, while still providing patients in […]
The U.S. Food and Drug Administration today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.
The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.
Delaware-based cheese manufacturer Roos Foods, Inc. has pleaded guilty to one criminal misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act (FFDCA) by introducing adulterated food into interstate commerce.
Delaware-based cheese manufacturer Roos Foods, Inc. has pleaded guilty to one criminal misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act (FFDCA) by introducing adulterated food into interstate commerce.
Mahina Mele Farms, LLC is recalling the following products after FDA testing found Salmonella in macadamia nuts. Salmonella is 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 may be bloody), […]
The U.S. Food and Drug Administration today issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered […]
The U.S. Food and Drug Administration today cleared the Olympus TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. Olympus will voluntarily recall its original model currently being used in health care facilities and make the needed repair as quickly as possible.
On Friday, Jan. 8, U.S. District Judge Sam A. Lindsay entered a consent decree of permanent injunction between the United States and Downing Labs LLC, of Dallas, Texas, and the company’s co-owners, Ashley Michelle Downing and Christopher Van Downing, and pharmacist-in-charge, Roger E. Mansfield.
The U.S. Food and Drug Administration today approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and […]
The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and worth more than $400,000.
The U.S. Food and Drug Administration today announced new efforts to better understand how the agency can appropriately balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the United States. The FDA will convene stakeholders for a public workshop and has re-opened a public comment period on a […]
The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class […]