Istituzioni

FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease

Food and Drug Administration - Ve, 25/10/2019 - 19:55
FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease
Categorie: Istituzioni

FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity

Food and Drug Administration - Ve, 25/10/2019 - 19:46
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc.
Categorie: Istituzioni

Statement on concerns with medical device availability due to certain sterilization facility closures

Food and Drug Administration - Ve, 25/10/2019 - 17:30
In light of the possibility of continued ethylene oxide sterilization facility closures, FDA is again alerting the public to growing concerns about the future availability of sterile medical devices and impending medical device shortages.
Categorie: Istituzioni

Baby powder manufacturer voluntarily recalls products for asbestos

Food and Drug Administration - Ve, 25/10/2019 - 15:51
The FDA is alerting consumers of a voluntary recall by Johnson & Johnson of Johnson’s Baby Powder after FDA testing has found that a sample from one lot of the product contains chrysotile fibers, a type of asbestos.
Categorie: Istituzioni

Statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants

Food and Drug Administration - Gi, 24/10/2019 - 22:43
FDA statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants
Categorie: Istituzioni

Statement on the agency’s efforts to protect patients from potentially harmful drugs sold as homeopathic products

Food and Drug Administration - Gi, 24/10/2019 - 22:19
Today, the FDA is taking two new steps toward clarifying the agency’s approach on homeopathic products.
Categorie: Istituzioni

FDA approves new breakthrough therapy for cystic fibrosis

Food and Drug Administration - Gi, 24/10/2019 - 22:11
FDA approves breakthrough therapy Trikafta for patients 12 and older with cystic fibrosis who have at least one F508del mutation in the CFTR gene, estimated to represent 90% of the cystic fibrosis population.
Categorie: Istituzioni

Statement on agency’s first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis

Food and Drug Administration - Gi, 24/10/2019 - 16:50
Statement from Acting FDA Commissioner Ned Sharpless, M.D., on agency’s first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis
Categorie: Istituzioni

FDA grants first-ever modified risk orders to eight smokeless tobacco products

Food and Drug Administration - Ma, 22/10/2019 - 20:11
The FDA announced today that, for the first time, it has authorized the marketing of products through the modified risk tobacco product (MRTP) pathway. The authorizations are for eight Swedish Match USA, Inc. snus smokeless tobacco products sold under the “General” brand name.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is

Food and Drug Administration - Ve, 18/10/2019 - 20:18
Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety
Categorie: Istituzioni

Statement on continued progress enhancing patient access to high-quality, low-cost generic drugs

Food and Drug Administration - Me, 16/10/2019 - 17:51
Statement from Acting FDA Commissioner Ned Sharpless, M.D., on continued progress enhancing patient access to high-quality, low-cost generic drugs
Categorie: Istituzioni

FDA approves new treatment for patients with migraine

Food and Drug Administration - Ve, 11/10/2019 - 19:13
The U.S. Food and Drug Administration today approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Reyvow is not indicated for the preventive treatment of migraine.
Categorie: Istituzioni

FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens

Food and Drug Administration - Gi, 10/10/2019 - 18:40
Today, FDA allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens. The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test FDA has allowed to be marketed in the U.S. for Ebola Virus Disease (EVD).
Categorie: Istituzioni

FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth

Food and Drug Administration - Gi, 10/10/2019 - 16:21
FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth
Categorie: Istituzioni

Statement on consumer warning to stop using THC vaping products amid ongoing investigation into lung illnesses

Food and Drug Administration - Me, 09/10/2019 - 17:45
Statement from Acting FDA Commissioner Ned Sharpless, M.D., on consumer warning to stop using THC vaping products amid ongoing investigation into lung illnesses
Categorie: Istituzioni

FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic

Food and Drug Administration - Me, 09/10/2019 - 15:25
FDA approved Descovy in at-risk adults and adolescents for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.
Categorie: Istituzioni

FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder

Food and Drug Administration - Ma, 08/10/2019 - 18:21
FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder
Categorie: Istituzioni

FDA awards two grants for natural history studies in rare diseases

Food and Drug Administration - Ma, 08/10/2019 - 16:04
FDA awards two grants for natural history studies in rare diseases
Categorie: Istituzioni

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

Food and Drug Administration - Ma, 08/10/2019 - 15:31
FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
Categorie: Istituzioni

FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software

Food and Drug Administration - Ma, 01/10/2019 - 16:03
FDA is informing patients, health care professionals, IT staff in health care facilities and manufacturers of a set of cybersecurity vulnerabilities, referred to as “URGENT/11,” that—if exploited by a remote attacker—may introduce risks for medical devices and hospital networks
Categorie: Istituzioni
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