Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., and Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on FDA’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in

Food and Drug Administration - Me, 03/04/2019 - 15:16
FDA issues statement on agency’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adults
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices

Food and Drug Administration - Ma, 02/04/2019 - 20:22
Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

Food and Drug Administration - Ma, 02/04/2019 - 17:37
FDA is announcing a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.
Categorie: Istituzioni

USDA, EPA, and FDA Recognize April as Winning on Reducing Food Waste Month

Food and Drug Administration - Ma, 02/04/2019 - 17:00
The agencies kick off Winning on Reducing Food Waste Month by calling for greater collaboration with public, private, and nonprofit partners as well as state and local officials.
Categorie: Istituzioni

FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids

Food and Drug Administration - Ma, 02/04/2019 - 16:21
Agency issued two warning letters to operators of websites that illegally market potentially dangerous, unapproved and misbranded opioid medications.
Categorie: Istituzioni

FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards

Food and Drug Administration - Lu, 01/04/2019 - 17:07
FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance treatment strategies for helping youth addicted to nicotine as a result of the epidemic rise in teen use of e-cigarettes

Food and Drug Administration - Lu, 01/04/2019 - 15:36
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance treatment strategies for helping youth addicted to nicotine as a result of the epidemic rise in teen use of e-cigarettes
Categorie: Istituzioni

FDA approves new oral treatment for multiple sclerosis

Food and Drug Administration - Ve, 29/03/2019 - 23:20
FDA approves Mayzent (cladribine), a new oral drug to treat multiple sclerosis
Categorie: Istituzioni

Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

Food and Drug Administration - Ve, 29/03/2019 - 16:15
Helping to facilitate access to promising medicines for patients with serious or immediately life-threatening diseases or conditions when no comparable or satisfactory alternative therapy options are available is a high priority for the FDA.
Categorie: Istituzioni

FDA approves treatment for patients with a type of inflammatory arthritis

Food and Drug Administration - Gi, 28/03/2019 - 20:30
The FDA is approving Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis. This is the first time that the FDA has approved a treatment for non-radiographic axial spondyloarthritis (nr-axSpA). nr-axSpA is a type of inflammatory arthritis that causes inflammation in the spine and other symptoms
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

Food and Drug Administration - Gi, 28/03/2019 - 18:01
FDA announced several new actions as part of our commitment to ensure sound regulatory oversight of tobacco products and an effective application review process that considers the impact on public health.
Categorie: Istituzioni

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Subcommittee on Appropriations on FDA’s Fiscal Year 2020 budget

Food and Drug Administration - Gi, 28/03/2019 - 17:20
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Subcommittee on Appropriations on FDA’s Fiscal Year 2020 budget.
Categorie: Istituzioni

FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism

Food and Drug Administration - Me, 27/03/2019 - 20:40
FDA approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products

Food and Drug Administration - Me, 27/03/2019 - 20:06
FDA is taking new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products
Categorie: Istituzioni

FDA advances landmark policy changes to modernize mammography services and improve their quality

Food and Drug Administration - Me, 27/03/2019 - 15:19
FDA proposes landmark policy changes to modernize mammography services and improve their quality
Categorie: Istituzioni

FDA approves new oral drug to treat multiple sclerosis

Food and Drug Administration - Me, 27/03/2019 - 01:24
The U.S. Food and Drug Administration today approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility

Food and Drug Administration - Ma, 26/03/2019 - 19:26
The FDA is aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility. The EPA order was due to the presence of levels of ethylene oxide higher than the EPA found to be acceptable in air around the facility. The FDA has been closely monitoring the situation and working with device manufacturers affected by the closure to minimize any impact to patients who need access to these medical devices.
Categorie: Istituzioni

FDA approves new device for treating moderate to severe chronic heart failure in patients

Food and Drug Administration - Gi, 21/03/2019 - 19:25
Device to treat heart failure was given Breakthrough Device designation because it treats a life-threatening disease and addresses unmet clinical need.
Categorie: Istituzioni
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