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Food and Drug Administration--Press Releases



Press releases from FDA



Last Build Date: Wed, 13 Dec 2017 10:13:00 -0500

 



FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care

Wed, 13 Dec 2017 10:13:00 -0500

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 to a specific drug.



FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome

Tue, 12 Dec 2017 10:34:00 -0500

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.



FDA warns companies for promoting alternatives to street drugs

Tue, 12 Dec 2017 10:03:00 -0500

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.



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

Mon, 11 Dec 2017 13:07:00 -0500

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.



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

Mon, 11 Dec 2017 09:14:00 -0500

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.



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 Innovation

Thu, 07 Dec 2017 10:48:00 -0500

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

Thu, 07 Dec 2017 09:00:00 -0500

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



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

Mon, 04 Dec 2017 11:10:00 -0500

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

Fri, 01 Dec 2017 10:39:00 -0500

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

Thu, 30 Nov 2017 18:45:00 -0500

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

Thu, 30 Nov 2017 18:34:00 -0500

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



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

Thu, 30 Nov 2017 16:59:00 -0500

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

Thu, 30 Nov 2017 16:39:00 -0500

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



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"

Thu, 30 Nov 2017 10:32:00 -0500

FDA Commissioner Gottlieb provides testimony before the House Committee on Energy and Commerce on the agency’s implementation of the 21st Century Cures Act



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

Wed, 22 Nov 2017 11:08:00 -0500

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 approves first two-drug regimen for certain patients with HIV

Tue, 21 Nov 2017 14:47:00 -0500

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.



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

Tue, 21 Nov 2017 09:29:00 -0500

FDA Commissioner on steps to promote development of generic versions of opioids formulated to deter abuse



FDA approves first telehealth option to program cochlear implants remotely

Fri, 17 Nov 2017 14:45:00 -0500

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 to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls

Fri, 17 Nov 2017 09:03:00 -0500

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

Thu, 16 Nov 2017 15:35:00 -0500

FDA approves first adjuvant treatment for adult patients who are at a high risk of kidney cancer returning after a kidney has been removed.