FDA/CMS parallel review process makes test for efficient identification of multiple targeted therapy options available to health care professionals, patients and eligible Medicare beneficiaries sooner
Category Archives: Food Safety News
Virginia Diner, Inc. Issues Allergy Alert on Undeclared Peanut Allergen in Chocolate Covered Cashews 10 oz. cans
Virginia Diner, Inc. is voluntarily issuing a recall of 10 oz. cans of Plow & Hearth Chocolate Covered Cashews at Plow & Hearth’s locations and nationwide (Mail Order) as a precaution because they may contain peanuts and peanut allergens. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. A label mix up was discovered by a consumer who received and opened a Cashew Tower Set (3 individual cashew cans) of which one can, the 10 oz. Chocolate Covered Cashews, were found to have Salted Peanuts.
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Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Implementing the 21st Century Cures Act: An Update from FDA and NIH"
FDA Commissioner Gottlieb provides testimony before the House Committee on Energy and Commerce on the agency’s implementation of the 21st Century Cures Act
Leclerc Foods Issues Limited Voluntary Recall of Fit & Active Chocolatey Chip Protein Meal Bars – Due to Presence of Plastic Piece
Leclerc Foods has initiated a limited voluntary recall of a single lot of Fit & Active Chocolatey Chip Protein Meal Bars packages with UPC Code 41498-18695 and only affected products with a “best by” date of May 24, 2018.
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FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients
FDA approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.
FDA approves first two-drug regimen for certain patients with HIV
FDA approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment.
Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse
FDA Commissioner on steps to promote development of generic versions of opioids formulated to deter abuse
FDA approves first telehealth option to program cochlear implants remotely
FDA approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform.
Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls
Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts by the agency to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls
FDA expands approval of Sutent to reduce the risk of kidney cancer returning
FDA approves first adjuvant treatment for adult patients who are at a high risk of kidney cancer returning after a kidney has been removed.