Category Archives: FDA

Litigation Concerns Rise as FDA Proposes Reclassification of Tanning Beds

The Food and Drug Administration (FDA) issued a press release regarding its proposed order to reclassify sunlamp products from a Class I medical device (low risk) to a Class II medical device (moderate risk).  Additionally, the FDA is now recommending that persons under the age of 18 be warned to not use these products at all. The FDA press release notes that “[a]ccording to the American Academy of Dermatology, there is a 75 percent increase in the risk of melanoma, the deadliest type of skin…

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FDA Gets Aggressive With Companies Over Marketing of Alleged Diabetes Treatments

The U.S. Food and Drug Administration (FDA) has started its campaign to stop sales of multiple products advertised and labeled as diabetes treatments. According to data from 2011, over 25 million people in the U.S. have diabetes and perhaps more alarming is that 79 million people have prediabetes. Clearly there is a market for diabetes remedies. To read the rest of this blog post, please visit Risky Business: Avoiding Product Liability, Commercial, and Other Litigation

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Congress’ Concern with Heparin Supply

The United States Food and Drug Administration has determined more than 90 deaths were caused by contaminated Heparin imported from China in 2008.  Heparin is widely used as an injectable anticoagulant during heart surgery and kidney dialysis.  Last week, concern was raised in the United States House of Representatives regarding Shanghui International Holdings Ltd’s pending $4.7 acquisition of Smithfield Food Inc., which is a supplier of raw heparin.  House Republicans believe this business transaction could threaten the safety and availability of the drug.  Apparently, concerns…

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Weight Loss Products Recalled Due to Undeclared Ingredient

On July 19, 2013, dietary supplement company, Herbal Give Care LLC, issued a voluntary total recall of its products: Esbelin siloutte te and Esbelin siloutte Herbal Blend with L-Carnitine (30 Capsules). According to the manufacturer, Esbelin siloutte te is a fat burner that removes stored fat, achieving elimination through the urine and preventing fat accumulation. Additionally, the product is intended to promote healthy digestive functioning. The Esbelin siloutte Herbal Blend with L-Carnitine (30 capsules) product is used to help normalize nervous appetite, preventing fat accumulation…

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FDA Encouraging Hackers to Submit Medical Device Cybersecurity Flaws

On June 13, 2013, the Food and Drug Administration issued a safety communication to medical device manufacturers, hospitals, medical device user facilities, health care IT and biomedical engineers advising them to take steps to secure cybersecurity for medical devices and hospital networks.  The FDA warned that as medical devices are increasingly interconnected, via the internet or wireless devices, there is an increased risk of  cybersecurity breaches, which could affect how a medical device operates. The FDA advised that it has become aware of cybersecurity vulnerabilities…

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Foreign Manufacturer of Surgical Masks Hit With FDA Warning Letter

The U.S. Food and Drug Administration (FDA) recently issued a warning letter to a manufacturer of surgical masks.  The manufacturer, located in Taiwan, was subject to inspection by the FDA that revealed numerous violations of the Federal Food, Drug, and Cosmetic Act (the act).  The FDA determined that the masks (medical devices) were adulterated and misbranded under the act. Violations included failure to conform with current good manufacturing practice requirements of the Quality System found at Title 21, Code of Federal Regulations (CFR), Part 820;…

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Food and Drug Administration Sends Letter to Biosense Technologies Regarding Urinalysis Phone App

After months of complaints from experts that the uCheck app is a medical device that failed to seek FDA approval, the U.S. Food and Drug Administration send a letter this week to Biosense Technologies, the maker of uChek smartphone-enabled unrinanalysis system instructing it to seek 510(k) clearance of its mobile medical application or to convince the FDA that such clearance is not necessary. James Woods a deputy director with the FDA, stated in the letter, “Please note that though the types of urinalysis dipsticks…

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BIVIGAM Recall

On April 2, 2013, the FDA issued an urgent recall for BIVIGAM Immune Globulin Intravenous, 10 percent liquid, 100 mL sterile vial due to visible particles observed in the liquid.  The recalled products are from lot# 120016 with an expiration date of March 31, 2014.  BIVIGAM is made by Biotest Pharmaceuticals and is used to treat primary immune deficiency.…

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Food & Drug Administration Admits It Could

Food & Drug Administration (FDA) Commissioner Margaret Hamburg testified before the U.S. House Energy and Commerce Committee’s Oversight panel about the agency’s actions leading up to the outbreak of meningitis that was linked to a compounding pharmacy last year and admitted that she regretted that the FDA did not do more and was not more directly engaged. She also acknowledged that the FDA had stopped conducting routine inspections of compounders as it developed a guidance documents for their regulation.  The FDA had stopped inspections because…

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A Potential Godsend to Mothers-to-Be

After a 30-year hiatus, the Food and Drug Administration (FDA) has once again approved a drug to specifically treat morning sickness.  Diclegis, made by Canadian Duchesnay Inc., is scheduled to be available in June 2013.  Diclegis combines Vitamin B6 and antihistamine doxylamine in a time released formula to prevent nausea before it sets in. The same drug combination was marketed as Benedectin from the 1950’s to 1980’s.  Despite no conclusive medical evidence that it caused birth defects and court rulings in its favor, Merrell Dow…

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