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Press releases from FDA
Updated: 4 hours 58 min ago

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

7 hours 38 min ago
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.
Categories: FDA News

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

Tue, 12/12/2017 - 09:34
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.
Categories: FDA News

FDA warns companies for promoting alternatives to street drugs

Tue, 12/12/2017 - 09:03
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.
Categories: FDA News

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

Mon, 12/11/2017 - 12:07
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.
Categories: FDA News

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

Mon, 12/11/2017 - 08:14
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.
Categories: FDA News

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

Thu, 12/07/2017 - 09:48
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
Categories: FDA News

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

Thu, 12/07/2017 - 08:00
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation
Categories: FDA News

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, 12/04/2017 - 10:10
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.
Categories: FDA News

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

Fri, 12/01/2017 - 09:39
FDA approves first biosimilar for the treatment of certain breast and stomach cancers
Categories: FDA News

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, 11/30/2017 - 17:45
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
Categories: FDA News

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

Thu, 11/30/2017 - 17:34
FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder
Categories: FDA News

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

Thu, 11/30/2017 - 15:59
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
Categories: FDA News

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

Thu, 11/30/2017 - 15:39
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
Categories: FDA News

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, 11/30/2017 - 09:32
FDA Commissioner Gottlieb provides testimony before the House Committee on Energy and Commerce on the agency’s implementation of the 21st Century Cures Act
Categories: FDA News

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

Wed, 11/22/2017 - 10:08
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.
Categories: FDA News

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

Tue, 11/21/2017 - 13:47
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.
Categories: FDA News

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

Tue, 11/21/2017 - 08:29
FDA Commissioner on steps to promote development of generic versions of opioids formulated to deter abuse
Categories: FDA News

FDA approves first telehealth option to program cochlear implants remotely

Fri, 11/17/2017 - 13:45
FDA approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform.
Categories: FDA News

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, 11/17/2017 - 08:03
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
Categories: FDA News

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

Thu, 11/16/2017 - 14:35
FDA approves first adjuvant treatment for adult patients who are at a high risk of kidney cancer returning after a kidney has been removed.
Categories: FDA News