Food and Drug Administration

Statement on quality issues with certain Cardinal Health surgical gowns and packs

Gio, 16/01/2020 - 21:11
Statement from Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health on quality issues with certain Cardinal Health surgical gowns and packs
Categorie: Istituzioni

Statement on the Salinas-linked romaine lettuce E. coli O157:H7 outbreak and status update on investigation

Mer, 15/01/2020 - 21:27
Romaine outbreaks declared over, investigation advances, root cause analysis continues
Categorie: Istituzioni

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

Lun, 13/01/2020 - 22:28
Home Style Foods, Inc., a Michigan-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements.
Categorie: Istituzioni

FDA approves first generics of Eliquis

Ven, 10/01/2020 - 21:40
The U.S. Food and Drug Administration today approved two applications for first generics of Eliquis (apixaban) tablets.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review

Ven, 10/01/2020 - 18:47
Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs

Ven, 10/01/2020 - 18:44
GAO issued the report “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contains a single recommendation for the FDA -- that the agency publicly announce its plans to issue or revise guidance for these drug products. The FDA agrees and is actively working to accomplish this goal.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies

Ven, 10/01/2020 - 18:39
Enabling patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness is a core part of our mission. We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year. While we’ve unveiled parts of that plan already, we’ll be releasing its full detail shortly. As one part of that effort, we’re announcing some additional steps we’re taking right now to promote beneficial medical device innovation.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation

Ven, 10/01/2020 - 18:18
The FDA is releasing the Medical Device Safety Action Plan that outlines our vision for how FDA can continue to enhance our programs and processes to assure the safety of medical devices
Categorie: Istituzioni

FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors

Gio, 09/01/2020 - 21:28
FDA approved Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation
Categorie: Istituzioni

Trump Administration takes historic steps to lower U.S. prescription drug prices

Gio, 09/01/2020 - 20:28
The Trump Administration is taking steps to lower prescription drug prices by proposing a rule that could allow for the importation of certain drugs from Canada and issuing draft guidance explaining how manufacturers could import drugs, biological products originally intended for sale abroad.
Categorie: Istituzioni

FDA, USDA and EPA announce joint platform to streamline information about agricultural biotechnology products

Gio, 09/01/2020 - 17:26
FDA, USDA and EPA launch Unified Website for Biotechnology Regulation to streamline information about agriculture biotechnology products.
Categorie: Istituzioni

FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint

Ven, 03/01/2020 - 23:37
FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint
Categorie: Istituzioni

FDA approves new treatment for adults with migraine

Lun, 23/12/2019 - 20:26
FDA approves Ubrelvy (ubrogepant) tablets for the acute treatment of migraine with or without aura in adults.
Categorie: Istituzioni

FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies

Lun, 23/12/2019 - 17:23
FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting
Categorie: Istituzioni

FDA expands indication for continuous glucose monitoring system, first to replace fingerstick testing for diabetes treatment decisions

Ven, 20/12/2019 - 21:32
The U.S. Food and Drug Administration today expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes.
Categorie: Istituzioni

First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

Ven, 20/12/2019 - 21:20
FDA announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older.
Categorie: Istituzioni

FDA, DEA seize 44 websites advertising sale of illicit THC vaping cartridges to US consumers as part of Operation Vapor Lock

Ven, 20/12/2019 - 18:48
The FDA and the Drug Enforcement Administration have seized 44 websites advertising the sale of illicit THC vaping cartridges.
Categorie: Istituzioni

FDA takes efforts to improve quality of compounded drugs from outsourcing facilities through collaboration and education as part of new Center of Excellence

Gio, 19/12/2019 - 22:03
Today, the agency is announcing the Compounding Quality Center of Excellence – an initiative designed to improve the overall quality of compounded medicines.
Categorie: Istituzioni

Statement on National Academies of Sciences, Engineering, and Medicine report on framing opioid prescribing guidelines for acute pain

Gio, 19/12/2019 - 17:41
National Academies of Sciences, Engineering, and Medicine (NASEM) was tasked with providing a framework to evaluate current and future opioid prescribing to support a clinical practice guideline and to identify gaps in the evidence.
Categorie: Istituzioni

FDA approves new type of therapy to treat advanced urothelial cancer

Mer, 18/12/2019 - 23:26
FDA granted accelerated approval to Padcev, a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4 which is highly expressed in urothelial cancers
Categorie: Istituzioni