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FDA

Food and Drug Administration

  • FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements

    FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636132.htm
    Tue, 16 Apr 2019 12:42:00 -0400
  • FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices

    FDA informs companies that the agency is not approving their PMA applications and that they will have to remove their products from the market

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636114.htm
    Tue, 16 Apr 2019 11:49:00 -0400
  • Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

    FDA efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635925.htm
    Fri, 12 Apr 2019 15:40:00 -0400
  • FDA approves first targeted therapy for metastatic bladder cancer

    The FDA granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635906.htm
    Fri, 12 Apr 2019 13:32:00 -0400
  • Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk

    FDA provides updates on post-marketing study that agency ordered three manufacturers of duodenoscopes to conduct to prevent bacterial contamination of devices.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635889.htm
    Fri, 12 Apr 2019 10:43:00 -0400
  • FDA orders important safety labeling changes for Addyi

    FDA has issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi requiring the company to revise important safety information.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635847.htm
    Thu, 11 Apr 2019 15:24:00 -0400
  • FDA issues final rule on safety and effectiveness of consumer hand sanitizers

    FDA issues a final rule designed to help ensure that hand sanitizers available over-the-counter are safe and effective for those who rely on them. The rule establishes that certain active ingredients are not allowed to be used in OTC hand sanitizers, formally known as topical consumer antiseptic rub products, which are intended for use without water, that are marketed under the FDA’s OTC Drug Review.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635793.htm
    Thu, 11 Apr 2019 09:34:00 -0400
  • FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion

    FDA is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635720.htm
    Wed, 10 Apr 2019 11:21:00 -0400
  • USDA, EPA, and FDA Unveil Strategy to Reduce Food Waste

    The agencies announced the release of a federal interagency strategy to address food waste.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635654.htm
    Tue, 09 Apr 2019 15:37:00 -0400
  • FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture

    FDA approves a new treatment for osteoporosis in postmenopausal women at high risk of breaking a bone (fracture).

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635653.htm
    Tue, 09 Apr 2019 15:23:00 -0400
  • Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids

    Agency issued a drug safety communication to make doctors and patients aware of the labeling changes and the need for careful tapering to avoid side effects

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635640.htm
    Tue, 09 Apr 2019 15:07:00 -0400
  • FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment

    FDA today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received antiretroviral treatment for HIV.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635526.htm
    Mon, 08 Apr 2019 15:31:00 -0400
  • FDA warns about risks of using home use test strips that are pre-owned or not authorized for sale in U.S., including those for glucose, warfarin

    FDA warns about risks of using home use test strips that are pre-owned or not authorized for sale in U.S., including those for glucose, warfarin

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635478.htm
    Mon, 08 Apr 2019 11:25:00 -0400
  • FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

    FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635283.htm
    Thu, 04 Apr 2019 14:11:00 -0400
  • FDA expands approved use of metastatic breast cancer treatment to include male patients

    The FDA is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635276.htm
    Thu, 04 Apr 2019 13:43:00 -0400
  • FDA and CBP bolster collaboration to protect public health and safety

    The U.S. Food and Drug Administration and the U.S. Customs and Border Protection (CBP) leaders signed an agreement today to maximize inspection and detection capabilities.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635270.htm
    Thu, 04 Apr 2019 13:30:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue

    FDA announces list of nitrosamine-free ARB medications confirmed by the agency to help patients and healthcare providers

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635251.htm
    Thu, 04 Apr 2019 10:31:00 -0400
  • Declaración del comisionado de la FDA sobre los esfuerzos continuos para impedir que las clínicas de células madre comercialicen productos no aprobados, y que reitera al mismo tiempo el compromiso de la dependencia de ayudar a avanzar en el desarrollo de productos legítimos de células madre bajo las regulaciones existentes

    Declaración de la FDA sobre las acciones de aplicación de las normas sobre células madre y las actividades de la dependencia para facilitar el desarrollo de productos legítimos

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635766.htm
    Wed, 10 Apr 2019 17:38:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs

    FDA shares its 2019 compounding priorities as the agency works to improve the quality of compounded drugs

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635182.htm
    Wed, 03 Apr 2019 12:26:00 -0400
  • FDA takes new steps to increase access to adverse event report data for medical products used in animals

    FDA takes new steps to increase access to adverse event report data for medical products used in animals

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635166.htm
    Wed, 03 Apr 2019 11:25:00 -0400

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