The U.S. Food and Drug Administration today approved the first genetic test that can help some colorectal cancer (CRC) patients and their doctors determine if the drug Erbitux (cetuximab) would be an effective treatment based on the presence of a gene mutation.
Category Archives: Food Safety News
BI-LO Issues Class II Recall On Southern Home Brand Bacon Ranch Salad Mix & Creamy Parmesan Salad Mix
Today BI-LO announced an immediate Class II voluntary recall of two store brand products, the Southern Home Bacon Ranch Salad Mix and the Southern Home Creamy Parmesan Salad Mix. According to the Food & Drug Administration (FDA), the reason for the recall is the potential for the product to contain small metal fragments.
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FDA prompts companies to remove certain unapproved oxycodone products from market
The U.S. Food and Drug Administration today issued a Federal Register notice instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone. The notice is part of the FDA’s Unapproved Drugs Initiative to remove unapproved new drugs from the market.
FDA approves first DNA test to help manage CMV infection in organ transplant patients
The U.S. Food and Drug Administration today approved the first DNA test to help health care professionals gauge the progress of anti-viral treatment in solid organ transplant patients undergoing cytomegalovirus (CMV) antiviral therapy.
FDA approves first over-the-counter home use HIV test kit
The U.S. Food and Drug Administration today approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
FDA proposes unique device identification system for medical devices
FDA proposes that most medical devices distributed in the United States carry a unique device identifier or UDI.
Mars Petcare US Announces Voluntary Recall of Limited Range of Pedigree ® Brand Wet Dog Food
Today, Mars Petcare US announced a voluntary recall of a limited range of three varieties of PEDIGREE® weight management canned dog food products due to a potential choking risk.Affected product may contain small pieces of blue plastic, which entered the food during the production process.
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Standard Process Issues Voluntary Recall of Three Supplements Because of Possible Health Risk
Standard Process Inc. of Palmyra, WI 53156 is voluntarily recalling the following three dietary supplements due to potential Salmonella contamination:
Cataplex ACP (Product number 0700 and 0750) Lot 114
Cataplex C (Product number 1650 1655) Lot 114
Pancreatrophin PMG (Product number 6650) Lot 114
The products, all tablets, were distributed in 60 cc and 200 cc amber glass bottles with Best Used By dates (BUB) of 5/13 indicated on both the bottles and the boxes.
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FDA approves Myrbetriq for overactive bladder
The U.S. Food and Drug Administration today approved Myrbetriq (mirabegron) to treat adults with overactive bladder, a condition in which the bladder muscle cannot be controlled, squeezes too often or squeezes without warning.
FDA approves Belviq to treat some overweight or obese adults
The U.S. Food and Drug Administration today approved Belviq (lorcaserin hydrochloride), as an addition to a reduced-calorie diet and exercise, for chronic weight management.