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 […]
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
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 […]
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 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. Read The Complete Story!
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 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.
FDA Commissioner on steps to promote development of generic versions of opioids formulated to deter abuse
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 by the agency to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls
FDA approves first adjuvant treatment for adult patients who are at a high risk of kidney cancer returning after a kidney has been removed.
FDA approves new treatment to prevent or reduce frequency of bleeding episodes in patients with hemophilia A who have Factor VIII inhibitors.