Istituzioni

Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products

Food and Drug Administration - Ma, 19/06/2018 - 21:03
Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply

Food and Drug Administration - Ma, 19/06/2018 - 16:27
FDA releases draft guidance to help food manufacturers implement the Intentional Adulteration rule under the FDA Food Safety Modernization Act
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products

Food and Drug Administration - Ve, 15/06/2018 - 16:04
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products
Categorie: Istituzioni

FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence

Food and Drug Administration - Gi, 14/06/2018 - 22:49
: FDA approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food

Food and Drug Administration - Gi, 14/06/2018 - 15:26
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making

Food and Drug Administration - Ma, 12/06/2018 - 16:44
FDA issues draft guidance on collecting patient experiences to inform the development and evaluation of medical products
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections

Food and Drug Administration - Ma, 12/06/2018 - 16:20
The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. FDA is taking steps to combat antibiotic-resistant bacteria.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

Food and Drug Administration - Ma, 12/06/2018 - 15:33
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care
Categorie: 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
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