Istituzioni

FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices

Food and Drug Administration - Ma, 16/04/2019 - 17:49
FDA informs companies that the agency is not approving their PMA applications and that they will have to remove their products from the market
Categorie: Istituzioni

FDA approves first targeted therapy for metastatic bladder cancer

Food and Drug Administration - Ve, 12/04/2019 - 19:32
The FDA granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.
Categorie: Istituzioni

Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk

Food and Drug Administration - Ve, 12/04/2019 - 16:43
FDA provides updates on post-marketing study that agency ordered three manufacturers of duodenoscopes to conduct to prevent bacterial contamination of devices.
Categorie: Istituzioni

FDA orders important safety labeling changes for Addyi

Food and Drug Administration - Gi, 11/04/2019 - 21:24
FDA has issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi requiring the company to revise important safety information.
Categorie: Istituzioni

FDA issues final rule on safety and effectiveness of consumer hand sanitizers

Food and Drug Administration - Gi, 11/04/2019 - 15:34
FDA issues a final rule designed to help ensure that hand sanitizers available over-the-counter are safe and effective for those who rely on them. The rule establishes that certain active ingredients are not allowed to be used in OTC hand sanitizers, formally known as topical consumer antiseptic rub products, which are intended for use without water, that are marketed under the FDA’s OTC Drug Review.
Categorie: Istituzioni

Declaración del comisionado de la FDA sobre los esfuerzos continuos para impedir que las clínicas de células madre comercialicen productos no aprobados, y que reitera al mismo tiempo el compromiso de la dependencia de ayudar a avanzar en el desarrollo de

Food and Drug Administration - Me, 10/04/2019 - 23:38
Declaración de la FDA sobre las acciones de aplicación de las normas sobre células madre y las actividades de la dependencia para facilitar el desarrollo de productos legítimos
Categorie: Istituzioni

FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion

Food and Drug Administration - Me, 10/04/2019 - 17:21
FDA is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI.
Categorie: Istituzioni

USDA, EPA, and FDA Unveil Strategy to Reduce Food Waste

Food and Drug Administration - Ma, 09/04/2019 - 21:37
The agencies announced the release of a federal interagency strategy to address food waste.
Categorie: Istituzioni

FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture

Food and Drug Administration - Ma, 09/04/2019 - 21:23
FDA approves a new treatment for osteoporosis in postmenopausal women at high risk of breaking a bone (fracture).
Categorie: Istituzioni

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment

Food and Drug Administration - Lu, 08/04/2019 - 21:31
FDA today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received antiretroviral treatment for HIV.
Categorie: Istituzioni

FDA warns about risks of using home use test strips that are pre-owned or not authorized for sale in U.S., including those for glucose, warfarin

Food and Drug Administration - Lu, 08/04/2019 - 17:25
FDA warns about risks of using home use test strips that are pre-owned or not authorized for sale in U.S., including those for glucose, warfarin
Categorie: Istituzioni

FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

Food and Drug Administration - Gi, 04/04/2019 - 20:11
FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications
Categorie: Istituzioni

FDA expands approved use of metastatic breast cancer treatment to include male patients

Food and Drug Administration - Gi, 04/04/2019 - 19:43
The FDA is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.
Categorie: Istituzioni

FDA and CBP bolster collaboration to protect public health and safety

Food and Drug Administration - Gi, 04/04/2019 - 19:30
The U.S. Food and Drug Administration and the U.S. Customs and Border Protection (CBP) leaders signed an agreement today to maximize inspection and detection capabilities.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs

Food and Drug Administration - Me, 03/04/2019 - 18:26
FDA shares its 2019 compounding priorities as the agency works to improve the quality of compounded drugs
Categorie: Istituzioni

FDA takes new steps to increase access to adverse event report data for medical products used in animals

Food and Drug Administration - Me, 03/04/2019 - 17:25
FDA takes new steps to increase access to adverse event report data for medical products used in animals
Categorie: Istituzioni
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