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FDA

Food and Drug Administration

  • FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing

    FDA approves drug to reduce the risk of stage III non-small cell lung cancer progressing

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm597217.htm
    Fri, 16 Feb 2018 16:48:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D. on the efficacy of the 2017-2018 influenza vaccine

    FDA provides update on flu vaccines during this severe flu season

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm597077.htm
    Thu, 15 Feb 2018 16:20:00 -0500
  • FDA expands treatment window for use of clot retrieval devices in certain stroke patients

    FDA expands treatment window for use of clot retrieval devices in certain stroke patient

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596983.htm
    Thu, 15 Feb 2018 12:20:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D. on advancing the development of novel treatments for neurological conditions; part of broader effort on modernizing FDA’s new drug review programs

    FDA’s 5 guidance documents provide details for drug development for neurological conditions such as ALS and Alzheimer’s disease

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596897.htm
    Thu, 15 Feb 2018 09:31:00 -0500
  • FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint

    FDA approves Erleada (apalutamide), first treatment for non-metastatic, castration-resistant prostate cancer

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596768.htm
    Wed, 14 Feb 2018 13:46:00 -0500
  • FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults

    FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults; new quick testing option to help reduce need for CT scans, radiation exposure for patients

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596531.htm
    Wed, 14 Feb 2018 13:21:00 -0500
  • FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients

    FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596575.htm
    Tue, 13 Feb 2018 15:58:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to promote innovation and broaden patient access through competition

    Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to promote innovation and broaden patient access through competition

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596554.htm
    Tue, 13 Feb 2018 15:33:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on groundbreaking approval and interagency approach to bring stable supply of critical medical imaging isotope to the U.S.

    FDA announces on groundbreaking approval and interagency approach to bring stable supply of critical medical imaging isotope to the U.S.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm595996.htm
    Thu, 08 Feb 2018 11:43:00 -0500
  • FDA and NRC pave way for the first domestic supply of the most commonly used medical isotope in diagnostic imaging

    FDA and NRC today took important steps to ensure a stable and secure supply of a critical radioactive imaging product used to detect potentially life-threatening diseases

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm595990.htm
    Thu, 08 Feb 2018 11:26:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse

    FDA statement on scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm595622.htm
    Tue, 06 Feb 2018 14:06:00 -0500
  • Statement from Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on the recent National Toxicology Program draft report on radiofrequency energy exposure

    One part of the Food and Drug Administration’s mission is to ensure the safety of electronic products that emit radiation, like televisions and cell phones. These types of products are part of Americans’ daily life and we take our duty to protect consumers with the utmost gravity. With cell phones, we have relied extensively on a myriad scientific evidence developed over many years to help inform our regulatory thinking. Although the Federal Communications Commission (FCC) sets the standard for radiofrequency energy exposure limits from cell phones, the FCC relies on the FDA and other health agencies for scientific expertise and input regarding those standards.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm595144.htm
    Fri, 02 Feb 2018 13:11:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to mitigate impact of saline shortages during this flu season

    FDA provides update on ongoing efforts to mitigate impact of saline shortages and monitor other critical products during flu season

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm595020.htm
    Thu, 01 Feb 2018 15:18:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products

    Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm594443.htm
    Tue, 30 Jan 2018 10:34:00 -0500
  • FDA, USDA announce formal agreement to bolster coordination and collaboration

    FDA Commissioner Dr. Scott Gottlieb and USDA Secretary Perdue launched an effort today to increase collaboration, efficiency and effectiveness, and provide clarity to food producers.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm594424.htm
    Tue, 30 Jan 2018 09:38:00 -0500
  • FDA approves new treatment for certain digestive tract cancers

    FDA approves first radioactive drug for a certain type of digestive tract cancer called GEP-NETs

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm594043.htm
    Fri, 26 Jan 2018 11:55:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s strengthened commitments to humane and judicious animal research and the termination of a nicotine study

    FDA strengthens commitments to humane and judicious animal research and the termination of a nicotine study

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm594009.htm
    Fri, 26 Jan 2018 10:21:00 -0500
  • FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims

    FDA and FTC issued joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm593602.htm
    Wed, 24 Jan 2018 10:28:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy steps for strengthening public warning and notification of recalls

    FDA discusses new policy steps for strengthening public warning and notification of recalls

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592777.htm
    Thu, 18 Jan 2018 15:16:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review

    Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592632.htm
    Tue, 16 Jan 2018 14:36:00 -0500

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