Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs

FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics

Food and Drug Administration - Gi, 06/12/2018 - 16:58
FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products

Food and Drug Administration - Gi, 06/12/2018 - 15:32
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of vitro companion diagnostics for classes of oncology therapeutic products
Categorie: Istituzioni

FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care

Food and Drug Administration - Ma, 04/12/2018 - 17:12
FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care
Categorie: Istituzioni

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

Food and Drug Administration - Ve, 30/11/2018 - 21:51
FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus
Categorie: Istituzioni

FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan

Food and Drug Administration - Gi, 29/11/2018 - 15:27
FDA issued a warning letter to Electric Lotus LLC for selling nicotine-containing e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products.
Categorie: Istituzioni

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

Food and Drug Administration - Gi, 29/11/2018 - 00:10
FDA approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder. This is the first FDA approval of a treatment for LEMS.
Categorie: Istituzioni

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

Food and Drug Administration - Me, 28/11/2018 - 21:38
The FDA approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
Categorie: Istituzioni

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

Food and Drug Administration - Me, 28/11/2018 - 19:10
The FDA approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway

Food and Drug Administration - Ma, 27/11/2018 - 21:58
FDA Commissioner statement on modernizing the 510(k) pathway by creating policies that rely on newer predicates with modern characteristics related to their safety and performance
Categorie: Istituzioni

Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products

Food and Drug Administration - Ma, 27/11/2018 - 17:02
FDA scientists tested 26 separate kratom products and found lead and nickel at levels not considered safe for human consumption
Categorie: Istituzioni

FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients

Food and Drug Administration - Ma, 27/11/2018 - 15:31
FDA issues a warning to consumers to beware of and avoid certain male enhancement products that may be dangerous to their health
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce <i>E. coli</i> O157:H7 outbreak investigation

Food and Drug Administration - Ma, 27/11/2018 - 00:41
Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation
Categorie: Istituzioni

FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

Food and Drug Administration - Lu, 26/11/2018 - 23:28
The FDA granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker).
Categorie: Istituzioni

FDA approves new treatment for patients with acute myeloid leukemia

Food and Drug Administration - Me, 21/11/2018 - 18:57
The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.
Categorie: Istituzioni

FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder

Food and Drug Administration - Ma, 20/11/2018 - 21:36
FDA issued warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety

Food and Drug Administration - Ma, 20/11/2018 - 17:30
FDA provides updates on medical device safety action plan describing recent actions we’ve taken to enhance device safety including implementation of NEST and registries on women’s health.
Categorie: Istituzioni

FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

Food and Drug Administration - Ma, 20/11/2018 - 15:32
The FDA approved Gamifant (emapalumab-lzsg) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk

Food and Drug Administration - Lu, 19/11/2018 - 18:54
FDA issues a qualified health claim for oleic acid oils based on data showing it reduces cholesterols levels.
Categorie: Istituzioni
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