Istituzioni

FDA approves first treatment for post-partum depression

Food and Drug Administration - Ma, 19/03/2019 - 23:37
FDA approves Zulresso (brexanolone), the first drug for post-partum depression
Categorie: Istituzioni

FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

Food and Drug Administration - Ma, 19/03/2019 - 21:34
FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements
Categorie: Istituzioni

FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions

Food and Drug Administration - Ma, 19/03/2019 - 15:57
FDA warned Nutra Pharma for illegally marketing unapproved products with claims about their ability to treat addiction, pain and other serious conditions.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions

Food and Drug Administration - Ve, 15/03/2019 - 18:24
The FDA is working to further evaluate materials like metals that are used in medical devices to learn more about how these materials interact with the immune system.
Categorie: Istituzioni

FDA allows marketing of new device to help treat carbon monoxide poisoning

Food and Drug Administration - Gi, 14/03/2019 - 22:53
FDA allows marketing of a new device, ClearMate, intended to be used with patients suffering from carbon monoxide poisoning. This is the first carbon monoxide poisoning device authorized for marketing by the FDA for use in an emergency room setting.
Categorie: Istituzioni

Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development

Food and Drug Administration - Gi, 14/03/2019 - 19:45
FDA issues statement on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development
Categorie: Istituzioni

FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitation

Food and Drug Administration - Gi, 14/03/2019 - 17:16
Device is for treatment of patients to reduce mitral regurgitation in certain patients with heart failure symptoms who fail to respond to traditional therapy
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars

Food and Drug Administration - Me, 13/03/2019 - 15:30
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars.
Categorie: Istituzioni

FDA approves a new generic valsartan

Food and Drug Administration - Ma, 12/03/2019 - 21:39
FDA has approved a new generic of Diovan (valsartan). The agency prioritized the review of this drug application to help relieve a recent shortage of the drug.
Categorie: Istituzioni

Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services

Food and Drug Administration - Ma, 12/03/2019 - 16:06
A federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes, prevent youth access and initiation; and harness innovation to advance

Food and Drug Administration - Lu, 11/03/2019 - 19:35
FDA is requesting new funding to continue to advance robust regulatory framework for oversight of e-cigarettes and harness innovation to advance the safety of food, compounded drugs, U.S. blood supply.
Categorie: Istituzioni

FDA takes steps to help reduce risks associated with surgical staplers and implantable staples

Food and Drug Administration - Ve, 08/03/2019 - 21:41
FDA takes steps to help reduce risks associated with surgical staplers and implantable staples
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered salmon

Food and Drug Administration - Ve, 08/03/2019 - 18:59
Statement from FDA Commissioner Scott Gottlieb, M.D., on continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered salmon
Categorie: Istituzioni

USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry

Food and Drug Administration - Gi, 07/03/2019 - 19:59
USDA’s Food Safety and Inspection Service and FDA announce a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products

Food and Drug Administration - Gi, 07/03/2019 - 17:02
FDA updates draft guidance to set a clear path for the nonproprietary naming of interchangeable biosimilars.
Categorie: Istituzioni

FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic

Food and Drug Administration - Me, 06/03/2019 - 02:07
FDA approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults with treatment-resistant depression
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is

Food and Drug Administration - Ma, 05/03/2019 - 21:18
Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan

Food and Drug Administration - Lu, 04/03/2019 - 19:55
Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan.
Categorie: Istituzioni
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