GIANT Food Stores, LLC and MARTIN’S Food Markets announced it removed from sale GIANT/MARTIN’S Brand Frozen Whole Kernel Sweet Corn due to potential Listeria monocytogenes contamination. Read The Complete Story!
Giant Food, LLC announced it removed from sale Giant Brand Frozen Whole Kernel Sweet Corn due to potential Listeria monocytogenes contamination. Read The Complete Story!
The Stop & Shop Supermarket Company LLC announced it removed from sale Stop & Shop Brand Frozen Whole Kernel Sweet Corn due to potential Listeria monocytogenes contamination. Read The Complete Story!
Commissioner statement on FDA’s comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy
FDA announces comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy.
Newly authorized test detects genetic cancer mutations in 468 unique genes
FDA approves treatment for rare genetic enzyme disorder
FDA permits marketing of the first device for use in helping to reduce the symptoms of opioid withdrawal
A botanical substance known as kratom has raised significant concerns given its increasing prevalence and potential safety risks. The FDA has issued a public health advisory related to mounting concerns regarding risks associated with the use of kratom.
The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and […]
Figi’s Companies, Inc of Marshfield, WI is recalling the following 2 products that are related to the GKI FOODS LLC Dark Chocolate Products recall because it may contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life- threatening allergic reaction if they consume these […]
Germack Roasting Co, is recalling its 5 ounce and 1lb packages of Germack Dark Chocolate Almond Bark because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products. Read The Complete Story!
To further streamline the submission and review process for shared system REMS (for any REMS that includes more than one medication), today the FDA is releasing a draft guidance for industry, Use of a Drug Master File for Shared System REMS Submissions, that describes how applicants can submit collective sets of files to the FDA […]
FDA menu labeling guidance
The U.S. Food and Drug Administration today cleared a complete blood cell count (CBC) test that, based on its categorization, can be run in more health care settings, including physicians’ offices, clinics or other types of health care facilities, by a wider range of personnel (e.g. support staff). This broadened test access will allow for […]
FDA expands approval of Zelboraf (vemurafenib) to include treatment of certain adult patients with Erdheim-Chester Disease, a rare blood cancer. This is the first FDA-approved treatment for ECD.
Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency’s streamlined development and review pathway for consumer tests that evaluate genetic health risks
FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer
In cooperation with the GKI Foods, LLC recall of dark chocolate products due to an undeclared milk/dairy allergen, Shoreline Fruit is voluntarily recalling select Shoreline Fruit bulk and Cherry Bay Orchards® branded dark chocolate covered cherry products. This recall is an extension of the GKI Foods LLC recall announced on October 27, 2017. People who […]