The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products.
Category Archives: Food Safety News
FDA approves new orphan drug to treat a form of Gaucher disease
The U.S. Food and Drug Administration today approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder.
FDA permits marketing of a new device for abdominal surgery
On April 30, the U.S. Food and Drug Administration today allowed marketing of the first surgical instrument set that can be assembled and disassembled inside the body during surgery.
The Percutaneous Surgical Set is intended to be used during minimally invasive laparoscopic abdominal surgery, in which a camera and surgical instruments are inserted through one or more small incisions (surgical cuts into body tissue) in the abdomen.
Diamond Pet Foods Expands Voluntary Recall to Include Diamond Puppy Formula due to Possible Salmonella Contamination
Diamond Pet Foods is expanding a voluntary recall to include Diamond Puppy Formula dry dog food. The company took this precautionary measure because sampling revealed Salmonella in the product.
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FDA approves new antibacterial treatment for plague
The U.S. Food and Drug Administration today approved Levaquin (levofloxacin) to treat patients with plague, a rare and potentially deadly bacterial infection. The agency also approved the drug to reduce the risk of getting plague after exposure to Yersinia pestis, the bacterium that causes the disease.
FDA challenges marketing of DMAA products for lack of safety evidence
The U.S. Food and Drug Administration today issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.
FDA approves Stendra for erectile dysfunction
The U.S. Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction.
Diamond Pet Foods Expands Voluntary Recall of One Production Run of Dry Dog Food Due to a Potential Health Risk Recall is limited to one formula of Chicken Soup for the Pet Lover’s Soul distributed to 10 states
Diamond Pet Foods is expanding a voluntary recall to include one production run and four production codes of Chicken Soup for the Pet Lover’s Soul Adult Light formula dry dog food. One bag of the product has tested positive for Salmonella, and the recall of the four production codes is being conducted as a precautionary measure.
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FDA Statement on USDA Announcement of Positive BSE Test Result
This week, the U.S. Department of Agriculture (USDA) confirmed that a dairy cow in California tested positive for atypical bovine spongiform encephalopathy (BSE, or “mad cow” disease). The USDA also confirmed the cow did not enter the animal feed or human food supply. The U.S. Food and Drug Administration is working with federal and state authorities to further investigate this case.
FDA approves Afinitor for non-cancerous kidney tumors caused by rare genetic disease
The U.S. Food and Drug Administration today approved Afinitor (everolimus), the first drug approved specifically to treat non-cancerous kidney tumors (renal angiomyolipomas) not requiring immediate surgery in patients with tuberous sclerosis complex (TSC).