The U.S. Food and Drug Administration today approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate, the self-contained, inch-long device is implanted directly in the […]
The U.S. Food and Drug Administration today approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate, the self-contained, inch-long device is implanted directly in the […]
The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA.
The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA.
The U.S. Food and Drug Administration today finalized a new food safety rule under the landmark FDA Food Safety Modernization Act (FSMA) that will help to prevent food contamination during transportation. The rule will require those involved in transporting human and animal food by motor or rail vehicle to follow recognized best practices for sanitary […]
Roland Foods, LLC, of New York, NY, in cooperation with the manufacturer in Peru, is initiating a voluntary recall of specific lots of Roland Fire Roasted Red Pepper Strips due to the possible presence of glass fragments in the product, therefore posing a potential health hazard. Read The Complete Story!
Alimentos Congelados, S.A. (Pinula) is voluntarily recalling 1,800 cases of Frozen Broccoli Cuts because it has the potential to 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 […]
The U.S. Food and Drug Administration is taking steps to reduce inorganic arsenic in infant rice cereal, a leading source of arsenic exposure in infants. Relative to body weight, rice intake for infants, primarily through infant rice cereal, is about three times greater than for adults. Moreover, national intake data show that people consume the […]
The U.S. Food and Drug Administration today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation (HSCT). This is the first FDA-approved therapy for treatment of […]
The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus.
American Gourmet of Vista, CA is recalling American Gourmet Roasted/Salted Pistachios because they may be contaminated with Salmonella. American Gourmet was informed by its Pistachio supplier to initiate a voluntary recall. Read The Complete Story!
The U.S. Food and Drug Administration today issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug.
The U.S. Food and Drug Administration today approved Cinqair (reslizumab) for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older. Cinqair is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.
The U.S. Food and Drug Administration today approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis.
In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration today announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, […]
Today, the U.S. Food and Drug Administration announced a proposal to ban most powdered gloves in the United States. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through […]
On Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.
MFA Incorporated today announced the recall of bagged and bulk MFA 16% and 17% rabbit feed. The product was distributed to MFA retail stores in southwest Missouri. Read The Complete Story!
Texas Star Nut & Food Company expands the previous Recall issued on March 10, 2016, to include the following items and Best by Dates. Read The Complete Story!