Istituzioni

FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse

Food and Drug Administration - Gi, 29/03/2018 - 19:26
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
Categorie: Istituzioni

Federal judge approves consent decree with New York dietary supplement manufacturer Riddhi USA

Food and Drug Administration - Gi, 29/03/2018 - 16:37
A New York dietary supplement manufacturer has been ordered by a federal court to stop selling its products until the company comes into compliance with the FDA’s dietary supplement manufacturing regulations.
Categorie: Istituzioni

Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs

Food and Drug Administration - Me, 28/03/2018 - 16:42
Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs
Categorie: Istituzioni

FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices

Food and Drug Administration - Ma, 27/03/2018 - 21:14
The authorization classifies integrated continuous glucose monitoring devices in class II and subjects them to certain criteria called special controls
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities

Food and Drug Administration - Ve, 23/03/2018 - 16:34
Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities
Categorie: Istituzioni

Statement from FDA’s Donald St. Pierre on findings from ongoing investigation into lead testing issues

Food and Drug Administration - Gi, 22/03/2018 - 20:41
FDA on findings from ongoing investigation into lead testing issues; studies find chemical interaction during test processing may contribute to skewing results
Categorie: Istituzioni

FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

Food and Drug Administration - Ma, 20/03/2018 - 20:31
FDA approves Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco products

Food and Drug Administration - Ma, 20/03/2018 - 14:59
FDA takes steps to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco products.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels

Food and Drug Administration - Gi, 15/03/2018 - 15:11
FDA takes pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels.
Categorie: Istituzioni

FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk

Food and Drug Administration - Ve, 09/03/2018 - 17:32
FDA has issued warning letters to Olympus, FujiFilm and Pentax, for failing to comply with section 522 orders on postmarket surveillance studies for duodenoscopes
Categorie: Istituzioni

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigations hearing “Examining U.S. Public Health Preparedness for and Response Effo

Food and Drug Administration - Gi, 08/03/2018 - 19:45
Commissioner remarks as prepared for testimony at the hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.”
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on effort to help bolster U.S. shellfish market by taking mutually beneficial steps to resume shellfish trade with the EU

Food and Drug Administration - Gi, 08/03/2018 - 17:53
FDA announces proposed shellfish equivalence determination with the EU that will create new market access for U.S. exporters as well as make a wider selection of healthy and safe shellfish options available to consumers. It will also assure American consumers that imported molluscan shellfish from Europe is as safe as what we produce in the U.S.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related to the ongoing post-market review of Essure and FDA’s commitment to keep women informed

Food and Drug Administration - Me, 07/03/2018 - 21:52
The FDA is actively evaluating a significant increase in the number of medical device reports submitted to the agency on the Essure device from October to December 2017
Categorie: Istituzioni

FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply

Food and Drug Administration - Me, 07/03/2018 - 02:06
FDA approves first tests to screen for tickborne parasite in blood donations
Categorie: Istituzioni

FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world

Food and Drug Administration - Ma, 06/03/2018 - 20:52
FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world
Categorie: Istituzioni

FDA approves new HIV treatment for patients who have limited treatment options

Food and Drug Administration - Ma, 06/03/2018 - 20:13
The FDA approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies.
Categorie: Istituzioni

FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes

Food and Drug Administration - Ma, 06/03/2018 - 16:44
FDA has authorized 23andMe to market a consumer test that reports only 3 out of more than 1,000 known mutations in BRCA genes
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s commitment to modernizing food and nutrition programs

Food and Drug Administration - Lu, 05/03/2018 - 20:42
FDA announces commitment to modernize and streamline our food and nutrition programs to make sure that our investments of new and existing resources achieve their intended public health goals.
Categorie: Istituzioni

FDA warns of fraudulent and unapproved flu products

Food and Drug Administration - Ve, 02/03/2018 - 20:41
FDA warns of fraudulent and unapproved flu products
Categorie: Istituzioni

FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company; agency seeks action to stop production and distribution

Food and Drug Administration - Ve, 02/03/2018 - 00:34
FDA is alerting not to use drug products produced by Cantrell Drug Company that were distributed nationwide.
Categorie: Istituzioni
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