FDA approves first treatment for breast cancer with a certain inherited genetic mutation
Category Archives: Food Safety News
FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues
FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues
FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use
The U.S. Food and Drug Administration announced today that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.
Dollar General Announces Voluntary Recall of Clover Valley® Iced Oatmeal Cookies Over Undeclared Milk and Tree Nuts
Dollar General Corporation announced a voluntary recall of its 12-ounce packages of Clover Valley® Iced Oatmeal Cookies with lot # L46217 30 with a best-by date of August 18, 2018 over concerns of undeclared milk and tree nuts. Consumers with a milk and/or nut allergy or sensitivity to these items should not consume these products due to a possible health risk or serious allergic reaction. No illnesses or reactions have been reported at this time.
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Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages
Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization Act enforcement discretion guidance
FDA announced today guidance outlining four key areas that it does not intend to enforce in the FDA Food Safety Modernization Act rules. The provisions relate to the “farm” definition, requirements related to written assurances from a manufacturer’s customers, requirements for importers of food contact substances, and requirements related to certain human food by-products for use as animal food.
FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell
FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product
California Popsicle, Inc. Issues Allergy Alert on Undeclared Milk in Ice Bars
California Popsicle, Inc. dba Polly Ann Ice Cream of South San Francisco, CA is recalling ice bars, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
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Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices
FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. FDA is releasing two documents that together will improve aspects of the submission and review of generic drug applications (known as Abbreviated New Drug Applications, or ANDAs).
FDA permits marketing of device to treat diabetic foot ulcers
FDA permits marketing of device to treat diabetic foot ulcers