Istituzioni

Federal judge enters consent decree against Delta Pharma

Food and Drug Administration - Ve, 08/06/2018 - 22:39
Federal judge enters consent decree against Delta Pharma
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products

Food and Drug Administration - Gi, 07/06/2018 - 19:41
Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products
Categorie: Istituzioni

FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens

Food and Drug Administration - Me, 06/06/2018 - 22:27
FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens
Categorie: Istituzioni

FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act

Food and Drug Administration - Me, 06/06/2018 - 16:31
FDA’s Anna Abram’s testimony for U.S. House Committee on Energy and Commerce Subcommittee on Health on the Pandemic and All-Hazards Preparedness Act
Categorie: Istituzioni

FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers

Food and Drug Administration - Ma, 05/06/2018 - 20:19
FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers by aligning USDA program with FDA’s Produce Safety Rule requirements.
Categorie: Istituzioni

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

Food and Drug Administration - Ma, 05/06/2018 - 17:27
FDA announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.
Categorie: Istituzioni

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

Food and Drug Administration - Ma, 05/06/2018 - 16:08
FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.
Categorie: Istituzioni

FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment

Food and Drug Administration - Lu, 04/06/2018 - 22:53
FDA approves Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA’s drug review office

Food and Drug Administration - Lu, 04/06/2018 - 14:55
FDA has proposed an important series of new steps to modernize the organization and functions of CDER’s Office of New Drugs.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities

Food and Drug Administration - Gi, 31/05/2018 - 20:23
FDA’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities
Categorie: Istituzioni

FDA approves first artificial iris

Food and Drug Administration - Me, 30/05/2018 - 21:13
FDA approves first artificial iris, a surgically implanted device to treat aniridia or other damage to the iris
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo

Food and Drug Administration - Me, 30/05/2018 - 20:43
FDA committed to helping the people of the Democratic Republic of Congo effectively confront and end the current Ebola virus outbreak
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act

Food and Drug Administration - Me, 30/05/2018 - 18:20
FDA stands ready to implement the Right to Try Act in a way that achieves Congress’ intent to promote access and protect patients
Categorie: Istituzioni

FDA approves new treatment for moderately to severely active ulcerative colitis

Food and Drug Administration - Me, 30/05/2018 - 18:12
FDA today expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis.
Categorie: Istituzioni

As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion

Food and Drug Administration - Me, 30/05/2018 - 15:17
As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion
Categorie: Istituzioni

FDA approves a new treatment for PKU, a rare and serious genetic disease

Food and Drug Administration - Gi, 24/05/2018 - 23:43
The FDA today approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU).
Categorie: Istituzioni

FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures

Food and Drug Administration - Gi, 24/05/2018 - 22:11
FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures
Categorie: Istituzioni

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

Food and Drug Administration - Me, 23/05/2018 - 15:20
OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

Food and Drug Administration - Ma, 22/05/2018 - 18:19
The FDA is announcing three new efforts as part of a comprehensive set of actions to advance the FDA’s framework for sun protection products ahead of this coming summer
Categorie: Istituzioni
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