Istituzioni

FDA approves device for treatment of acute coronary artery perforations

Food and Drug Administration - Ve, 14/09/2018 - 18:08
FDA approves device for treatment of acute coronary artery perforations
Categorie: Istituzioni

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s commitment to studying breast implant safety

Food and Drug Administration - Ve, 14/09/2018 - 17:49
FDA Statement on agency’s commitment to studying breast implant safety Short Title: FDA Statement on agency’s commitment to studying breast implant safety
Categorie: Istituzioni

FDA approves new kind of treatment for hairy cell leukemia

Food and Drug Administration - Gi, 13/09/2018 - 19:54
FDA approves Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukemia
Categorie: Istituzioni

FDA awards five grants to advance the development of pediatric medical devices

Food and Drug Administration - Me, 12/09/2018 - 18:27
FDA has awarded grants to five Pediatric Device Consortia that will provide advice to innovators of children's medical devices
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use

Food and Drug Administration - Me, 12/09/2018 - 15:32
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use
Categorie: Istituzioni

FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access

Food and Drug Administration - Me, 12/09/2018 - 15:22
FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom

Food and Drug Administration - Ma, 11/09/2018 - 16:58
Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom
Categorie: Istituzioni

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

Food and Drug Administration - Lu, 10/09/2018 - 20:07
WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.
Categorie: Istituzioni

FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence

Food and Drug Administration - Ve, 07/09/2018 - 22:18
FDA approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

Food and Drug Administration - Ve, 07/09/2018 - 16:24
FDA announces revised draft memorandum of understanding between FDA and the states to help ensure the quality of and preserve access to compounded drugs
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on an updated approach for including added sugar information on the Nutrition Facts labels of pure maple syrup and honey

Food and Drug Administration - Gi, 06/09/2018 - 16:04
Proposed rule revises front of package calorie labeling requirements to provide more flexibility to industry
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

Food and Drug Administration - Me, 05/09/2018 - 17:22
FDA is publishing its internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections in an effort to ensure the quality and safety of globally produced products.
Categorie: Istituzioni

La FDA ayuda a facilitar el comercio entre los socios comerciales estadounidenses y extranjeros con un nuevo programa de certificación de exportaciones para los alimentos

Food and Drug Administration - Ve, 31/08/2018 - 23:26
La FDA ayuda a facilitar el comercio entre los socios comerciales estadounidenses y extranjeros con un nuevo programa de certificación de exportaciones para los alimentos
Categorie: Istituzioni

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

Food and Drug Administration - Ve, 31/08/2018 - 19:07
FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles
Categorie: Istituzioni

FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food

Food and Drug Administration - Ve, 31/08/2018 - 15:33
FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food
Categorie: Istituzioni

District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

Food and Drug Administration - Gi, 30/08/2018 - 22:24
The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law

Food and Drug Administration - Me, 29/08/2018 - 20:43
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law
Categorie: Istituzioni
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