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FDA

Food and Drug Administration

  • FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients

    FDA approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm586405.htm
    Wed, 22 Nov 2017 11:08:00 -0500
  • FDA approves first two-drug regimen for certain patients with HIV

    FDA approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm586305.htm
    Tue, 21 Nov 2017 14:47:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse

    FDA Commissioner on steps to promote development of generic versions of opioids formulated to deter abuse

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm586117.htm
    Tue, 21 Nov 2017 09:29:00 -0500
  • FDA approves first telehealth option to program cochlear implants remotely

    FDA approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585767.htm
    Fri, 17 Nov 2017 14:45:00 -0500
  • Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls

    Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts by the agency to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585720.htm
    Fri, 17 Nov 2017 09:03:00 -0500
  • FDA expands approval of Sutent to reduce the risk of kidney cancer returning

    FDA approves first adjuvant treatment for adult patients who are at a high risk of kidney cancer returning after a kidney has been removed.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585657.htm
    Thu, 16 Nov 2017 15:35:00 -0500
  • FDA approves new treatment to prevent bleeding in certain patients with hemophilia A

    FDA approves new treatment to prevent or reduce frequency of bleeding episodes in patients with hemophilia A who have Factor VIII inhibitors.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585567.htm
    Thu, 16 Nov 2017 11:26:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health

    Commissioner statement on FDA’s comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585342.htm
    Thu, 16 Nov 2017 09:23:00 -0500
  • FDA announces comprehensive regenerative medicine policy framework

    FDA announces comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585345.htm
    Thu, 16 Nov 2017 09:22:00 -0500
  • FDA unveils a streamlined path for the authorization of tumor profiling tests alongside its latest product action

    Newly authorized test detects genetic cancer mutations in 468 unique genes

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585347.htm
    Wed, 15 Nov 2017 13:16:00 -0500
  • FDA approves treatment for rare genetic enzyme disorder

    FDA approves treatment for rare genetic enzyme disorder

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585308.htm
    Wed, 15 Nov 2017 12:10:00 -0500
  • FDA grants marketing authorization of the first device for use in helping to reduce the symptoms of opioid withdrawal

    FDA permits marketing of the first device for use in helping to reduce the symptoms of opioid withdrawal

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585271.htm
    Wed, 15 Nov 2017 11:17:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom

    A botanical substance known as kratom has raised significant concerns given its increasing prevalence and potential safety risks. The FDA has issued a public health advisory related to mounting concerns regarding risks associated with the use of kratom.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584970.htm
    Tue, 14 Nov 2017 08:58:00 -0500
  • FDA warns about illegal use of injectable silicone for body contouring and associated health risks

    FDA issues safety communication about illegal use of injectable silicone for body contouring and associated health risks

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584517.htm
    Tue, 14 Nov 2017 09:59:00 -0500
  • FDA approves pill with sensor that digitally tracks if patients have ingested their medication

    The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm
    Mon, 13 Nov 2017 19:00:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access

    To further streamline the submission and review process for shared system REMS (for any REMS that includes more than one medication), today the FDA is releasing a draft guidance for industry, Use of a Drug Master File for Shared System REMS Submissions, that describes how applicants can submit collective sets of files to the FDA that represent all participating firms.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584259.htm
    Wed, 08 Nov 2017 11:00:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on a practical approach to ensuring timely implementation of FDA’s menu labeling rule

    FDA menu labeling guidance

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584147.htm
    Tue, 07 Nov 2017 18:10:00 -0500
  • FDA clears common blood cell count test that offers faster results for patients and providers

    The U.S. Food and Drug Administration today cleared a complete blood cell count (CBC) test that, based on its categorization, can be run in more health care settings, including physicians’ offices, clinics or other types of health care facilities, by a wider range of personnel (e.g. support staff). This broadened test access will allow for faster availability of results.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583997.htm
    Mon, 06 Nov 2017 14:23:00 -0500
  • FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer

    FDA expands approval of Zelboraf (vemurafenib) to include treatment of certain adult patients with Erdheim-Chester Disease, a rare blood cancer. This is the first FDA-approved treatment for ECD.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583931.htm
    Mon, 06 Nov 2017 11:31:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency’s streamlined development and review pathway for consumer tests that evaluate genetic health risks

    Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency’s streamlined development and review pathway for consumer tests that evaluate genetic health risks

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583885.htm
    Mon, 06 Nov 2017 09:25:00 -0500

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