The U.S. Food and Drug Administration announced today two actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. These actions include a new, mandatory clinical study for Essure to determine heightened risks for particular women and draft guidance with labeling recommendations including a boxed warning label and a checklist for doctors to discuss potential risks of implanted permanent birth control devices with patients. Since Essure’s approval in 2002, the agency has continued to monitor Essure’s safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. The new actions announced today take additional steps and follow the agency’s careful evaluation of available information.
Category Archives: Food & Drug Recalls
FDA providing $2 million in new grants for natural history studies in rare diseases
The U.S. Food and Drug Administration today announced the availability of $2 million in research grants to fund natural history studies in rare diseases. The aim is to collect data on how specific rare diseases progress in individuals over time so that knowledge can inform and support product development and approval. This will be the first time the FDA will provide funding through its Orphan Products Grants to conduct these types of studies for rare diseases.
FDA providing $2 million in new grants for natural history studies in rare diseases
The U.S. Food and Drug Administration today announced the availability of $2 million in research grants to fund natural history studies in rare diseases. The aim is to collect data on how specific rare diseases progress in individuals over time so that knowledge can inform and support product development and approval. This will be the first time the FDA will provide funding through its Orphan Products Grants to conduct these types of studies for rare diseases.
Abbott Issues Voluntary Safety Notice on MitraClip® Delivery System Deployment Process
Abbott has initiated a voluntary safety notice regarding the MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device. The company received a small number of reports involving MitraClip Delivery Systems where the user was unable to separate the implantable Clip from the delivery system. Presently, there are 3,534 devices on the market (1,288 in the United States and 2,246 outside the United States). Abbott has received nine Medical Device Reports of malfunction.
Maytag Dairy Farms Expands Voluntary Recall Of Blue Cheese Products Due To Possible Health Risk
Maytag Dairy Farms is expanding its voluntary recall of Maytag Blue blue cheese wedges, wheels and crumbles because they have the potential to be contaminated with Listeria monocytogenes. The organism can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
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Federal judge approves consent decree with Florida dietary supplement distributor, Viruxo
A Florida dietary supplement distributor has been ordered by a federal court to stop selling its product, which it claimed could treat herpes.
Federal judge approves consent decree with Florida dietary supplement distributor, Viruxo
A Florida dietary supplement distributor has been ordered by a federal court to stop selling its product, which it claimed could treat herpes.
FDA Statement on Senate Confirmation of Dr. Robert M. Califf
FDA Statement on Senate Confirmation of Dr. Robert Califf
Lipari Foods Issues Allergy Alert on Dark Chocolate Covered Coffee Bean Products Due to Undeclared Almonds
Lipari Foods, LLC has issued a voluntary recall of dark chocolate covered coffee beans packaged by sister company JLM due to an undeclared allergen of tree nuts (almonds). People who have an allergy or severe sensitivity to almonds run the risk of a serious or life-threatening allergic reaction if they consume these products.
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Lipari Foods Issues Allergy Alert on Dark Chocolate Covered Coffee Bean Products Due to Undeclared Almonds
Lipari Foods, LLC has issued a voluntary recall of dark chocolate covered coffee beans packaged by sister company JLM due to an undeclared allergen of tree nuts (almonds). People who have an allergy or severe sensitivity to almonds run the risk of a serious or life-threatening allergic reaction if they consume these products.
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