Bellisio Foods, Inc., a Jackson, Ohio, manufacturer, is voluntarily recalling certain Michelina’s Fettuccine Alfredo due to the possibility some packages may contain undeclared chicken with soy that is not listed on packaging. People who have an allergy or sensitivity to soy may run the risk of serious allergic reaction(s) if they consume this product.
Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs
GAO issued the report “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contains a single recommendation for the FDA — that the agency publicly announce its plans to issue or revise guidance for these drug products. The FDA agrees and is actively working to accomplish this goal.
FDA Commissioner Scott Gottlieb, M.D., updates on some ongoing shortages related to IV fluids
FDA updates on some ongoing shortages related to IV fluids
FDA and DoD launch program to expedite availability of medical products for the emergency care of American military personnel
The U.S. Food and Drug Administration and the Department of Defense launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel.
FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs
FDA takes steps to enhance transparency of clinical trial data used in support of new drug approvals
Hiland Dairy Announces Voluntary Recall Of Hiland Dairy Orange Juice And Tampico Citrus Punch
Hiland Dairy is announcing a voluntary recall of two products produced at the Omaha, Nebraska facility, over concerns the products may contain milk protein that could affect those individuals that have sensitivity to milk allergens. 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. No illnesses or allergic reactions have been reported at this time.
Rico Brand Issues Allergy Alert on Undeclared Soy in Tofu Breakfast Burrito
Rico Brand of Salt Lake City, Utah is recalling Tofu Breakfast Burrito, because it may contain undeclared Soy. People who have an allergy or severe sensitivity to Soy run the risk of serious or life-threatening allergic reaction if they consume these products.
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
: FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
FDA approves first treatment for breast cancer with a certain inherited genetic mutation
FDA approves first treatment for breast cancer with a certain inherited genetic mutation