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 mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.
Category Archives: Food Safety News
Figi’s Issues Recall Alert Due to Undeclared Allergen (Milk) in Dark Chocolate Gingersnaps
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 products.
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GKI Issues Allergy Alert On Undeclared Milk In Dark Chocolate Almond Bark
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.
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Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access
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process for shared system REMS (for any REMS that includes more than one medication), today the FDA is releasing a draft guidance for industry, Use of a Drug Master File for Shared System REMS Submissions, that describes how applicants can submit collective sets of files to the FDA that represent all participating firms.
Statement from FDA Commissioner Scott Gottlieb, M.D., on a practical approach to ensuring timely implementation of FDA’s menu labeling rule
FDA menu labeling guidance
FDA clears common blood cell count test that offers faster results for patients and providers
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 faster availability of results.
FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer
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
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
FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer
Shoreline Fruit, LLC. Recalls Select Bulk and Retail Dark Chocolate Covered Cherry Products Due to Possible Undeclared Milk Allergen
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 have an allergy or severe sensitivity to milk/dairy run the risk of a serious or life threatening allergic reaction if they consume these products.
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