Food and Drug Administration

FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups

Ve, 13/12/2019 - 22:24
FDA expands the indication of Vascepa (icosapent ethyl) capsules to reduce the risk of cardiovascular events as an adjunct to maximally tolerated statin therapy in high-risk adult patients with elevated triglyceride levels. It is a fish oil-derived omega-3 fatty acid product indicated to reduce the
Categorie: Istituzioni

FDA clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing

Ve, 13/12/2019 - 19:29
The FDA today cleared for marketing in the U.S. the first fully disposable duodenoscope. The EXALT Model D Single-Use Duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.
Categorie: Istituzioni

FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system

Ve, 13/12/2019 - 17:48
The FDA has authorized marketing of an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).
Categorie: Istituzioni

FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation

Gi, 12/12/2019 - 23:50
Today, the FDA approved a new treatment for Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) patients
Categorie: Istituzioni

Statement on new findings and current status of the romaine lettuce E. coli O157:H7 outbreak investigation

Gi, 12/12/2019 - 23:08
Illnesses subsiding, FDA continues to aggressively investigate source and route of contamination to prevent future outbreaks
Categorie: Istituzioni

FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk

Gi, 12/12/2019 - 22:43
FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access

Gi, 12/12/2019 - 19:08
FDA is announcing a public hearing to discuss access to affordable insulin products.
Categorie: Istituzioni

FDA authorizes first test to aid in newborn screening for Duchenne Muscular Dystrophy

Gi, 12/12/2019 - 17:47
Today, the U.S. Food and Drug Administration authorized marketing of the first test to aid in newborn screening for Duchenne Muscular Dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness.
Categorie: Istituzioni

FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

Me, 11/12/2019 - 17:14
FDA issues warning letter to Alkermes, Inc., for misbranding the drug Vivitrol (an extended-release injection formulation of naltrexone) by omitting warnings about the most serious risks associated with the drug from promotional materials
Categorie: Istituzioni

FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations

Ma, 10/12/2019 - 23:31
The U.S. Food and Drug Administration is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx.
Categorie: Istituzioni

Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S.

Ma, 10/12/2019 - 23:02
The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms.
Categorie: Istituzioni

FDA approves first generics of Gilenya

Gi, 05/12/2019 - 21:14
The U.S. Food and Drug Administration today approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients
Categorie: Istituzioni

FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria

Gi, 05/12/2019 - 17:52
Today, the U.S. Food and Drug Administration authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections. The cobas vivoDx MRSA
Categorie: Istituzioni

FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases

Gi, 05/12/2019 - 16:19
FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases
Categorie: Istituzioni

FDA approves novel treatment to target abnormality in sickle cell disease

Me, 04/12/2019 - 22:56
FDA granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease in adults and pediatric patients 12 years of age and older
Categorie: Istituzioni

FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health

Lu, 02/12/2019 - 18:32
FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health
Categorie: Istituzioni

Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient

Me, 27/11/2019 - 18:30
FDA issues guidance to help make development of biosimilar and interchangeable insulin products more efficient.
Categorie: Istituzioni

California-based food manufacturer agrees to stop production after repeated food safety violations

Ma, 26/11/2019 - 22:18
California-based food manufacturer agrees to stop production after repeated food safety violations
Categorie: Istituzioni

Statement on new steps to advance innovation in medical device sterilization with ethylene oxide

Ma, 26/11/2019 - 19:31
FDA is announcing the next steps in our ongoing efforts in medical device sterilization with ethylene oxide. This includes the selection results of our new Innovation Challenges, a recap and action items from our recent public advisory committee meeting, and the announcement of a new pilot program.
Categorie: Istituzioni