Food and Drug Administration

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Press releases from FDA
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FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes

Lu, 11/12/2017 - 19:07
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.
Categorie: Istituzioni

FDA launches public education campaign to encourage adult smokers trying to quit cigarettes

Lu, 11/12/2017 - 15:14
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 and that typically feature cigarette advertisements. The “Every Try Counts” campaign targets smokers ages 25-54 who have attempted to quit smoking in the last year but were unsuccessful. The two-year campaign launches next month in 35 U.S. markets and features print, digital, radio, and out-of-home ads, such as on billboards.
Categorie: Istituzioni

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical In

Gi, 07/12/2017 - 16:48
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
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation

Gi, 07/12/2017 - 15:00
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation
Categorie: Istituzioni

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices

Lu, 04/12/2017 - 17:10
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.
Categorie: Istituzioni

FDA approves first biosimilar for the treatment of certain breast and stomach cancers

Ve, 01/12/2017 - 16:39
FDA approves first biosimilar for the treatment of certain breast and stomach cancers
Categorie: Istituzioni

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

Ve, 01/12/2017 - 00:45
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
Categorie: Istituzioni

FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder

Ve, 01/12/2017 - 00:34
FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder
Categorie: Istituzioni

Statement by FDA Commissioner Scott Gottlieb, M.D., updating on Puerto Rico related medical product shortages

Gi, 30/11/2017 - 22:59
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
Categorie: Istituzioni

FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers

Gi, 30/11/2017 - 22:39
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
Categorie: Istituzioni

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"

Gi, 30/11/2017 - 16:32
FDA Commissioner Gottlieb provides testimony before the House Committee on Energy and Commerce on the agency’s implementation of the 21st Century Cures Act
Categorie: Istituzioni

FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients

Me, 22/11/2017 - 17:08
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.
Categorie: Istituzioni

FDA approves first two-drug regimen for certain patients with HIV

Ma, 21/11/2017 - 20:47
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.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse

Ma, 21/11/2017 - 15:29
FDA Commissioner on steps to promote development of generic versions of opioids formulated to deter abuse
Categorie: Istituzioni

FDA approves first telehealth option to program cochlear implants remotely

Ve, 17/11/2017 - 20:45
FDA approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform.
Categorie: Istituzioni

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls

Ve, 17/11/2017 - 15:03
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
Categorie: Istituzioni

FDA expands approval of Sutent to reduce the risk of kidney cancer returning

Gi, 16/11/2017 - 21:35
FDA approves first adjuvant treatment for adult patients who are at a high risk of kidney cancer returning after a kidney has been removed.
Categorie: Istituzioni

FDA approves new treatment to prevent bleeding in certain patients with hemophilia A

Gi, 16/11/2017 - 17:26
FDA approves new treatment to prevent or reduce frequency of bleeding episodes in patients with hemophilia A who have Factor VIII inhibitors.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health

Gi, 16/11/2017 - 15:23
Commissioner statement on FDA’s comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy
Categorie: Istituzioni

FDA announces comprehensive regenerative medicine policy framework

Gi, 16/11/2017 - 15:22
FDA announces comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy.
Categorie: Istituzioni