Istituzioni

FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies

Food and Drug Administration - Ma, 01/05/2018 - 16:29
FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies
Categorie: Istituzioni

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Committee on Appropriations on FDA’s Fiscal Year 2019 budget

Food and Drug Administration - Ma, 24/04/2018 - 21:09
FDA Commissioner Scott Gottlieb, M.D. remarks to a U.S. Senate Subcommittee on Appropriations on the FDA’s Fiscal Year 2019 budget
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new enforcement actions and a Youth Tobacco Prevention Plan to stop youth use of, and access to, JUUL and other e-cigarettes

Food and Drug Administration - Ma, 24/04/2018 - 16:21
FDA announces several new enforcement actions and a Youth Tobacco Prevention Plan to stop youth use of, and access to, JUUL and other e-cigarettes.
Categorie: Istituzioni

FDA authorizes new use of test, first to identify the emerging pathogen <i>Candida auris</i>

Food and Drug Administration - Ve, 20/04/2018 - 21:47
FDA authorized the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalized patients.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to encourage more widespread innovation and development of new treatments for opioid use disorder

Food and Drug Administration - Ve, 20/04/2018 - 16:09
FDA announces new steps to encourage more widespread innovation and development of new treatments for opioid use disorder
Categorie: Istituzioni

FDA takes new steps to advance the development of innovative products for treating opioid use disorder

Food and Drug Administration - Ve, 20/04/2018 - 16:05
FDA announces new steps to encourage and support the development of treatment options for people with opioid use disorder
Categorie: Istituzioni

Federal judge enters consent decree against Cantrell Drug Company

Food and Drug Administration - Ve, 20/04/2018 - 00:49
Cantrell Drug Company prohibited from manufacturing and distributing sterile drug products in violation of the law
Categorie: Istituzioni

Remarks from FDA Commissioner Scott Gottlieb, M.D. on Fiscal Year 2019 budget request for FDA

Food and Drug Administration - Ma, 17/04/2018 - 20:06
FDA Commissioner Scott Gottlieb, M.D. remarks to the U.S. House Committee on Appropriations on the FDA’s Fiscal Year 2019 budget
Categorie: Istituzioni

FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia

Food and Drug Administration - Ma, 17/04/2018 - 19:20
FDA approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare form of rickets.
Categorie: Istituzioni

Statement by Dr. Susan Mayne on FDA efforts to reduce consumer exposure to arsenic in rice

Food and Drug Administration - Ma, 17/04/2018 - 18:36
One way FDA oversees food safety is through monitoring of contaminants in food, such as arsenic, assessing potential exposure and taking steps to reduce exposure
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

Food and Drug Administration - Ma, 17/04/2018 - 16:48
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

La FDA toma medidas para proteger a los consumidores de los suplementos alimenticios que contienen niveles peligrosamente altos de cafeína altamente concentrada o pura

Food and Drug Administration - Sa, 14/04/2018 - 00:12
: El día de hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) tomó una medida importante para proteger mejor a los consumidores de los peligros de los productos de cafeína altamente concentrada y pura.
Categorie: Istituzioni

FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine

Food and Drug Administration - Ve, 13/04/2018 - 14:57
Today, the U.S. Food and Drug Administration took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products.
Categorie: Istituzioni

FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests

Food and Drug Administration - Gi, 12/04/2018 - 16:20
The FDA today finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments.
Categorie: Istituzioni

FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems

Food and Drug Administration - Me, 11/04/2018 - 17:18
FDA permits marketing of first medical device to use artificial intelligence to detect greater than a mild level of diabetic retinopathy in the eye of adults who have diabetes.
Categorie: Istituzioni

FDA clears first contact lens with light-adaptive technology

Food and Drug Administration - Ma, 10/04/2018 - 19:44
FDA clears first contact lens with additive that automatically darkens the lens when exposed to bright light
Categorie: Istituzioni

FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information

Food and Drug Administration - Lu, 09/04/2018 - 18:01
FDA is restricting the sale and distribution of the Essure device to only those health care providers who provide information to women about the risks and benefits of this device before they get the permanent contraception implant.
Categorie: Istituzioni

FDA orders mandatory recall for kratom products due to risk of salmonella

Food and Drug Administration - Ma, 03/04/2018 - 16:21
Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.
Categorie: Istituzioni

New York raw milk cheese company ordered to stop sales for food safety violations

Food and Drug Administration - Lu, 02/04/2018 - 16:56
FDA announces an enforcement action taken against Vulto Creamery of New York. The company cannot sell ready-to-eat raw cheese product until it complies with the consent decree. Vulto was linked to an outbreak last year.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to enhance the patient perspective and experience in drug development and review

Food and Drug Administration - Ve, 30/03/2018 - 15:08
FDA issues update to Benefit-Risk Assessment plan as part of efforts to enhance the patient perspective and experience in drug development and review
Categorie: Istituzioni
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