Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths

Food and Drug Administration - Gi, 17/01/2019 - 18:56
FDA describes unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths
Categorie: Istituzioni

FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy

Food and Drug Administration - Me, 16/01/2019 - 18:51
FDA approved the first generic version of Sabril for treating complex partial seizures, as an adjunctive therapy in certain patients.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations

Food and Drug Administration - Lu, 07/01/2019 - 18:27
FDA issues three documents that launch next phase of Pre-Cert Pilot Program to test new approaches for the review of digital health device applications.
Categorie: Istituzioni

FDA permits marketing of a diagnostic test to aid in measuring nutrients in breast milk

Food and Drug Administration - Ve, 21/12/2018 - 20:20
The FDA authorized use of a new test that measures nutrients in breast milk providing healthcare professionals with tool to aid in the nutritional management of newborns.
Categorie: Istituzioni

FDA approves new treatment for adult patients with rare, life-threatening blood disease

Food and Drug Administration - Ve, 21/12/2018 - 16:37
The FDA approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease.
Categorie: Istituzioni

FDA approves first treatment for rare blood disease

Food and Drug Administration - Ve, 21/12/2018 - 16:29
The FDA approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds

Food and Drug Administration - Gi, 20/12/2018 - 22:35
Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales

Food and Drug Administration - Gi, 20/12/2018 - 19:40
The FDA provides update on Essure postmarket review study as company prepares to halt sales of the device on December 31.
Categorie: Istituzioni

FDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation

Food and Drug Administration - Gi, 20/12/2018 - 17:50
FDA alerted parents, caregivers and health care providers to the safety risks that jewelry used for relieving teething pain pose for children.
Categorie: Istituzioni

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

Food and Drug Administration - Gi, 20/12/2018 - 16:03
FDA sends warning letter to Genetech, Inc. and letters to other companies to reiterate the FDA’s compliance and enforcement policy regarding stem cells.
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 new steps to promote innovations in medical devices that help advance patient safety

Food and Drug Administration - Ma, 18/12/2018 - 16:23
FDA announces steps being taken on two medical device programs: finalizing guidance on the Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s 2017 report on declining sales/distribution of antimicrobial drugs for food animals, a reflection of improved antimicrobial stewardship

Food and Drug Administration - Ma, 18/12/2018 - 15:42
FDA’s 2017 report of sales/distribution data for antimicrobial drugs for food animals showed a continued decline in sales, a reflection of improved antimicrobial stewardship
Categorie: Istituzioni

Michigan-based food manufacturer agrees to stop operations after repeated food safety violations

Food and Drug Administration - Lu, 17/12/2018 - 22:13
Saranac Brand Foods, Inc. specialized in a variety of 35 different ready-to-eat foods, including prepared salads, dips, and sauces.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce <i>E. coli</i> O157:H7 outbreak investigation

Food and Drug Administration - Gi, 13/12/2018 - 21:56
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice

Food and Drug Administration - Me, 12/12/2018 - 16:32
FDA releases guidance with recommendations for drug manufacturers regarding good manufacturing practices and data integrity
Categorie: Istituzioni

FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

Food and Drug Administration - Ma, 11/12/2018 - 23:55
FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework

Food and Drug Administration - Ma, 11/12/2018 - 15:55
FDA announces new actions advancing the agency’s biosimilars policy framework
Categorie: Istituzioni

Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data

Food and Drug Administration - Lu, 10/12/2018 - 22:27
FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.
Categorie: Istituzioni
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