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FDA

Food and Drug Administration

  • 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

    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

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628400.htm
    Thu, 13 Dec 2018 15:56:00 -0500
  • 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

    FDA announces withdrawal of the proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628339.htm
    Thu, 13 Dec 2018 09:22:00 -0500
  • 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

    FDA releases guidance with recommendations for drug manufacturers regarding good manufacturing practices and data integrity

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628244.htm
    Wed, 12 Dec 2018 10:32:00 -0500
  • FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

    FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628189.htm
    Tue, 11 Dec 2018 17:55:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework

    FDA announces new actions advancing the agency’s biosimilars policy framework

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628121.htm
    Tue, 11 Dec 2018 09:55:00 -0500
  • 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

    FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628096.htm
    Mon, 10 Dec 2018 16:27:00 -0500
  • FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

    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

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628091.htm
    Mon, 10 Dec 2018 15:23:00 -0500
  • 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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628029.htm
    Mon, 10 Dec 2018 10:26:00 -0500
  • 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

    FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627760.htm
    Thu, 06 Dec 2018 10:58:00 -0500
  • 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

    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

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627745.htm
    Thu, 06 Dec 2018 09:32:00 -0500
  • FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care

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

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627555.htm
    Tue, 04 Dec 2018 11:12:00 -0500
  • FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

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

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627310.htm
    Fri, 30 Nov 2018 15:51:00 -0500
  • FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan

    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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627123.htm
    Thu, 29 Nov 2018 09:27:00 -0500
  • FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

    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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627093.htm
    Wed, 28 Nov 2018 18:10:00 -0500
  • FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

    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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627072.htm
    Wed, 28 Nov 2018 15:38:00 -0500
  • FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

    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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627009.htm
    Wed, 28 Nov 2018 13:10:00 -0500
  • 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

    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

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626838.htm
    Tue, 27 Nov 2018 15:58:00 -0500
  • Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products

    FDA scientists tested 26 separate kratom products and found lead and nickel at levels not considered safe for human consumption

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626738.htm
    Tue, 27 Nov 2018 11:02:00 -0500
  • FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients

    FDA issues a warning to consumers to beware of and avoid certain male enhancement products that may be dangerous to their health

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626723.htm
    Tue, 27 Nov 2018 09:31:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation

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

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626716.htm
    Mon, 26 Nov 2018 18:41:00 -0500

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