Food and Drug Administration

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Press releases from FDA
Aggiornato: 19 ore 29 min fa

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

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

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

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

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

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

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

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

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

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

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

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

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. and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development

Gi, 13/12/2018 - 15:22
FDA announces withdrawal of the proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
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

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

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

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

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

FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

Lu, 10/12/2018 - 21:23
FDA clears a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder
Categorie: Istituzioni

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

Lu, 10/12/2018 - 16:26
FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.
Categorie: Istituzioni