Today the FDA is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond […]
FDA approves first drug for a rare autoimmune disease that causes an inflammation in the wall of blood vessels of the body. This is a new indication for a previously-approved drug.
The FDA today posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and misbranded drugs.
The FDA today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product.
Today, the U.S. Food and Drug Administration announced an adult smoking cessation education campaign aimed at encouraging cigarette smokers to quit through messages of support that underscore the health benefits of quitting. These messages will be displayed in and around gas stations and convenience stores – retail locations where smokers face a multitude of triggers […]
On Tuesday, December 5, a partner food pantry agency in Wamego, Kansas notified Harvesters—The Community Food Network of potentially contaminated Bibi Frutix candy product it received through Harvesters’ distribution program. The candy product is likely contaminated with a chemical substance and is potentially harmful if eaten.
In cooperation with Hofer KG ZNL Schokoladefab, ALDI has voluntarily recalled Choceur Dark Chocolate Bars as a precautionary measure due to the potential presence of almond pieces not listed on packaging. The recall was initiated after an ALDI employee identified almond pieces in the product. This product may cause an allergic reaction in customers who […]
FDA Commissioner Gottlieb testifies before the U.S. Senate Committee on Health, Education, Labor & Pensions on the agency’s implementation of the 21st Century Cures Act
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation
Creative Contract Packaging LLC is voluntarily recalling 4,412 cases, or 13,236 total pounds, of two code dates of HERB-OX® Beef Flavor Granulated Bouillon, due to the potential presence of an undeclared milk allergen.
Simple Diagnostics, is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues.
The Kroger Company has recalled Comforts FOR BABY Purified Water with Fluoride Added 1 GAL (3.78 L) with sell by dates from 4/26/2018 to 10/10/2018, after receiving complaints about mold in the product. Testing by Kroger has identified the mold as Talaromyces penicillium. The water is sold in clear containers, but the mold may not […]
The FDA is issuing final guidance on the technical considerations for the 3D printing of medical devices. The recommendations clarify what the FDA recommends manufacturers include in submissions for 3D printed medical products.
FDA approves first biosimilar for the treatment of certain breast and stomach cancers
Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments
FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder
Statement by FDA Commissioner Scott Gottlieb, M.D. on efforts by the agency to address the impact of IV saline products and amino acids for injection shortages following the hurricane and update on FDA’s work in Puerto Rico
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
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 […]