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FDA

Food and Drug Administration

  • FDA authorizes new use of test, first to identify the emerging pathogen Candida auris

    FDA authorized the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalized patients.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605336.htm
    Fri, 20 Apr 2018 15:47:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to encourage more widespread innovation and development of new treatments for opioid use disorder

    FDA announces new steps to encourage more widespread innovation and development of new treatments for opioid use disorder

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605235.htm
    Fri, 20 Apr 2018 10:09:00 -0400
  • FDA takes new steps to advance the development of innovative products for treating opioid use disorder

    FDA announces new steps to encourage and support the development of treatment options for people with opioid use disorder

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605248.htm
    Fri, 20 Apr 2018 10:05:00 -0400
  • Federal judge enters consent decree against Cantrell Drug Company

    Cantrell Drug Company prohibited from manufacturing and distributing sterile drug products in violation of the law

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605199.htm
    Thu, 19 Apr 2018 18:49:00 -0400
  • Remarks from FDA Commissioner Scott Gottlieb, M.D. on Fiscal Year 2019 budget request for FDA

    FDA Commissioner Scott Gottlieb, M.D. remarks to the U.S. House Committee on Appropriations on the FDA’s Fiscal Year 2019 budget

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604826.htm
    Tue, 17 Apr 2018 14:06:00 -0400
  • FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia

    FDA approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare form of rickets.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604810.htm
    Tue, 17 Apr 2018 13:20:00 -0400
  • Statement by Dr. Susan Mayne on FDA efforts to reduce consumer exposure to arsenic in rice

    One way FDA oversees food safety is through monitoring of contaminants in food, such as arsenic, assessing potential exposure and taking steps to reduce exposure

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604807.htm
    Tue, 17 Apr 2018 12:36:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation

    The FDA is releasing the Medical Device Safety Action Plan that outlines our vision for how FDA can continue to enhance our programs and processes to assure the safety of medical devices

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604672.htm
    Tue, 17 Apr 2018 10:48:00 -0400
  • La FDA toma medidas para proteger a los consumidores de los suplementos alimenticios que contienen niveles peligrosamente altos de cafeína altamente concentrada o pura

    : El día de hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) tomó una medida importante para proteger mejor a los consumidores de los peligros de los productos de cafeína altamente concentrada y pura.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604631.htm
    Fri, 13 Apr 2018 18:12:00 -0400
  • FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine

    Today, the U.S. Food and Drug Administration took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604485.htm
    Fri, 13 Apr 2018 08:57:00 -0400
  • FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests

    The FDA today finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604462.htm
    Thu, 12 Apr 2018 10:20:00 -0400
  • FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems

    FDA permits marketing of first medical device to use artificial intelligence to detect greater than a mild level of diabetic retinopathy in the eye of adults who have diabetes.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604357.htm
    Wed, 11 Apr 2018 11:18:00 -0400
  • FDA clears first contact lens with light-adaptive technology

    FDA clears first contact lens with additive that automatically darkens the lens when exposed to bright light

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604263.htm
    Tue, 10 Apr 2018 13:44:00 -0400
  • FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information

    FDA is restricting the sale and distribution of the Essure device to only those health care providers who provide information to women about the risks and benefits of this device before they get the permanent contraception implant.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604098.htm
    Mon, 09 Apr 2018 12:01:00 -0400
  • FDA orders mandatory recall for kratom products due to risk of salmonella

    Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm603517.htm
    Tue, 03 Apr 2018 10:21:00 -0400
  • New York raw milk cheese company ordered to stop sales for food safety violations

    FDA announces an enforcement action taken against Vulto Creamery of New York. The company cannot sell ready-to-eat raw cheese product until it complies with the consent decree. Vulto was linked to an outbreak last year.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm603372.htm
    Mon, 02 Apr 2018 10:56:00 -0400
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to enhance the patient perspective and experience in drug development and review

    FDA issues update to Benefit-Risk Assessment plan as part of efforts to enhance the patient perspective and experience in drug development and review

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm602999.htm
    Fri, 30 Mar 2018 09:08:00 -0400
  • FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse

    FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm603151.htm
    Thu, 29 Mar 2018 13:26:00 -0400
  • Federal judge approves consent decree with New York dietary supplement manufacturer Riddhi USA

    A New York dietary supplement manufacturer has been ordered by a federal court to stop selling its products until the company comes into compliance with the FDA’s dietary supplement manufacturing regulations.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm603111.htm
    Thu, 29 Mar 2018 10:37:00 -0400
  • Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs

    Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm602929.htm
    Wed, 28 Mar 2018 10:42:00 -0400

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